MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for INTERCEPT BLOOD SYSTEM FOR PLATELETS INT2510 manufactured by Cerus Corporation.
[110651155]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[110651156]
Transfusion transmitted infection - acinetobacter baumanii [transmission of an infectious agent via product]. Case narrative: date cerus received: 07-may-2018, 08-may-2018, 09-may-2018, 10-may-2018, 11-may-2018, 14-may-2018, 15-may-2018, 17-may-2018, 21-may-2018, 31-may-2018, 01-jun-2018, 03-jun-2018, 04-jun-2018, 05-jun-2018 (in). Patient demographics: (b)(6) year-old white male. Product complaint #: (b)(4). Product id # (din): (b)(4). Processing set lot #: ce17c24l61. Illuminator serial #: (b)(4). On 07-may-2018, cerus received a spontaneous serious adverse event report ((b)(4)) from dr. (b)(6), the transfusion service medical director at the (b)(6) medical center via a cerus employee in the united states. Further information on the initial report was received between 08-may-2018 to 04-jun-2018 from the following reporters: dr. (b)(6), chief medical officer of the (b)(6); dr. (b)(6), divisional medical officer, (b)(6); (b)(6), director of quality assurance, (b)(6); dr. (b)(6), chief of microbiology at (b)(6); dr. (b)(6), director at (b)(6); and dr (b)(6), (b)(6). This report involves a (b)(6)-year-old white male patient who experienced a serious adverse event of transfusion transmitted infection - acinetobacter baumanii [pt: transmission of an infectious agent via product] following transfusion of intercept platelet concentrates (pc). The patient? S primary diagnosis is acute lymphoblastic leukemia status post allogeneic stem cell transplant on (b)(6) 2017. The patient is currently undergoing chemotherapy for relapse. Concurrent conditions include neutropenia. [additional clinical information, e. G. , induction, consolidation, anc/wbc will be queried and added as received from the reporter. ] the patient is blood group o, rh negative. The patient? S concomitant medications included cefazolin. The patient did not have a reported history of transfusion reactions. On (b)(6) 2018, the patient was transferred to (b)(6) medical center for line-associated (b)(6) bacteremia due to hickman line catheter infection. The (b)(6) was confirmed with a (b)(6) blood culture on the same date. On (b)(6) 2018, the patient? S hickman line catheter was removed. Additional cultures were drawn on the following days and were consistently negative: (b)(6) 2018. On (b)(6) 2018, the patient experienced an abscess in his right shoulder which required incision and drainage (i & d). The (b)(6) infection was believed to be associated with the abscess in his right shoulder. On (b)(6) 2018, a swab sample taken from the patient? S right shoulder was gram stain negative. [query will be submitted to the reporter to clarify/confirm the specimen collection site, e. G. , skin surface, wound, drain, etc. , on the right shoulder. ] cultures revealed no growth. On the same date, a peripherally inserted central venous catheter (picc) line was placed in his left upper arm. The surgical wound drain was removed on (b)(6) 2018 and sutures removed on (b)(6) 2018. [query will be submitted to the reporter regarding culture results, if any, from the surgical wound drain. ] on an unspecified date, the patient was treated with cefazolin and responded well to treatment with plans for discharge on (b)(6) 2018. On (b)(6) 2018 10:46h, a 406 ml platelet donation was collected at (b)(6) via apheresis procedure on an amicus instrument. The apheresis collection run time was 100 minutes and suspension medium was pas-3. The donor is a blood type (b)(6); (b)(6) year-old female frequent platelet donor with no record of a positive bacterial screening culture in this or prior donations (bact/alert alarm codes). She did have a 1 year malaria travel deferral from 2015-2016. It was later revealed during the (b)(6) donor investigation that the she had an abdominal rash and a healing ~1 inch abscess on her back at the time of donation; which she did not report during routine donor screening. On the same date, the donated unit was processed with an intercept blood system dual storage (ds) processing set. On (b)(6) 2018, the donated unit (din: (b)(6)) was treated with the intercept blood system (treatment time: 00:32h? 00:38h at (b)(6) approximately 13. 5 hours after collection. The treatment report showed a successful treatment with no indication of malfunction or irregularities. Following treatment, the unit was split into two components: din: (b)(6). The expiration date of both units was 04-may-2018. On (b)(6) 2018 13:00h, the first component (din: (b)(4)) was shipped from (b)(4) depot. At 16:17h, the second component (din: (b)(4)) was received at the (b)(6) depot. On (b)(6) 2018 13:56h, the second component (din: (b)(4)) was shipped from (b)(4) to the (b)(6) depot. At 15:52h, the second component (din: (b)(4)) was received at the (b)(4) depot and placed into a controlled storage environment. On 03-may-2018 06:57h, the (b)(6) transfusion service received the implicated unit (din: (b)(4)) from (b)(4). Upon receipt from (b)(6), a visual check of the bags was performed by (b)(6) blood bank staff. This inspection revealed no abnormalities. A visual check was also performed at the time the product was issued to the floor. No irregularities were observed. On the same date from 12:30h-12:30h, the patient received an intercept pc (din: (b)(4)) transfusion without incident. On (b)(6) 2018 10:00h? 10:40h, the patient received 300 ml of the first of two intercept pc transfusions via his picc line without incident. This first unit (din: (b)(4)) is independent from the unit (din: (b)(4)) associated with the event of transfusion transmitted infection? Acinetobacter baumanii [pt: transmission of an infectious agent via product]. [query will be submitted to reporter to confirm whether the iv line connected to the picc line was the same used for spiking both bags]. Later that day, from 12:23h to 12:50h, the patient received 188 ml of a 2nd intercept pc transfusion (din: (b)(4)) for thrombocytopenia via his picc line and experienced a serious adverse event of transfusion transmitted infection? Acinetobacter baumanii [pt: transmission of an infectious agent via product]. The patient? S clinical status prior to the 2nd intercept pc transfusion was noted to be afebrile and generally stable with plans for discharge. At 12:23h, the patient? S pre-transfusion vitals were as follows: temperature: 36. 8 degrees celsius; blood pressure (bp): 134/88 mmhg; mean arterial pressure (map): 100 mmhg; heart rate (hr): 96 beats per minute (bpm); respiratory rate (rr): 16 bpm; oxygen saturation: 95%. At 12:50h, after the full unit was transfused, the patient was reported to have experienced chills/rigors and flushing which resolved quickly. The empty bag of the implicated unit was clamped and disconnected from the patient by the registered nurse (rn) who was covering a break period. When the primary rn returned from her break, the bag was still hanging on the iv pole but clamped with a cap at the end of the tubing. The patient? S post-transfusion vitals were as follows: temperature: 37. 6 degrees celsius; blood pressure (bp): 149/90 mmhg; mean arterial pressure (map): 102 mmhg; heart rate (hr): 117 beats per minute (bpm); respiratory rate (rr): 18 bpm; oxygen saturation: 100%. At 13:17h, the patient? S post-transfusion vitals were as follows: temperature: 37 degrees celsius; blood pressure (bp): 117/61 mmhg; mean arterial pressure (map): 75 mmhg; heart rate (hr): 140 beats per minute (bpm); respiratory rate (rr): not provided; oxygen saturation: 97%. At 15:00h, the patient developed fever, severe hypotension and tachycardia. The patient? S post-transfusion vitals at this time were as follows: temperature: 39. 3 degrees celsius; blood pressure (bp): 70/50 mmhg; mean arterial pressure (map): not provided; heart rate (hr): 145 beats per minute (bpm); respiratory rate (rr): 45 bpm; oxygen saturation: 92%. A code was called and the patient was treated with 1 liter bolus of vasopressors and calcium. At 15:27h, the patient was given a 1 gram vancomycin via iv. The patient was transferred to the icu for septic shock. In the icu, meropenem was added to the patient? S antibiotic regimen due to concern for septic shock. The patient was also given renal replacement therapy (rrt) for acute kidney injury and supportive care for acute hypoxemic respiratory failure. The implicated platelet bag was transferred with the patient to the icu. Of note, the patient? S platelet count prior to transfusion was 13 x 10^9 /l and increased to 20 x 10^9 /l post transfusion. [the patient? S wbc and anc values will be queried and added here when received from the reporter. ] at 17:00h, the transfusion reaction was reported to the ucsf blood bank. At 17:29h, blood samples were obtained from the patient? S picc line and peripheral vein and sent for immediate testing, including gram stain and bacterial culture. The implicated platelet bag was not placed in the garbage or biohazard waste. At 20:00h, the empty platelet bag was flushed out with 5 ml of sterile normal saline and samples for culture were taken on the bench in the ucsf laboratory. The implicated platelet bag was accessed through sterile docking with the original platelet tubing attached to the bag, and subjected to gram stain and culture. At 20:33h, results of the gram stain conducted on a 0. 1 ml sample of the saline flush from the platelet bag were read back to the nurse with the following results:? Few gram positive cocci in chains? And? Numerous gram positive cocci in pairs and clusters.? The platelet bag was examined carefully by (b)(6) blood bank staff after the transfusion reaction and no obvious leaks were identified. The post-transfusion specimen revealed no visual signs of hemolysis and polyspecific dat test was negative. On the same date, the co-component (din: (b)(4)), was recalled before it was transfused to another recipient. At 22:30h, a sample from the co-component (din: (b)(4)) was collected at (b)(6) prior to being sent back to (b)(6) for further testing, including bacterial culture. At approximately 23:00h, another sample was taken for a repeat gram stain on the implicated platelet bag. Of note, a pre-transfusion blood sample from the patient was not collected. On 05-may-2018, the re-called co-component (din: (b)(4)) was received at (b)(6). In addition, the following (b)(6) microbiology testing results on the patient, the implicated platelet bag, the saline used for flushing implicated platelet bag and the co-component were provided: patient (transfusion recipient): cultures on the samples taken post-transfusion from the patient? S central catheter line (the line through which the platelets were given) and peripheral vein were both positive for acinetobacter baumanii complex. It was also noted that the cultures from the picc line grew faster (15 hours and 54 minutes) than the sample taken from the patient? S veins (24 hours and 34 minutes). At 13:43h, the positive culture results were read back to the icu registered nurse. Antibiotic susceptibility results (central catheter (picc line) blood sample) for acinetobacter baumanii: ampicillin + sulbactam: <=4 susceptible; ceftazidime: 4 susceptible; ciprofloxacin: <=0. 5 susceptible; gentamicin: <=2 susceptible; levofloxacin: < =1 susceptible; piperacillin + tazobactam: <=8 susceptible; tobramycin: <=2 susceptible; trimethoprim sulfamethoxazole bactrim: < =2 susceptible. Implicated platelet bag (din: (b)(4)): on the same date, gram stain and cultures performed on the samples taken from the implicated platelet bag (din: (b)(4)) were positive. The repeat gram stain of the saline flushed platelet bag showed a positive gram stain with? Numerous gram positive cocci in pairs and clusters.? The initial culture on the saline-flushed platelet bag was positive for acinetobacter baumanii complex and staphylococcus saprophyticus. Time to positivity was 14 hours and 41 minutes. Antibiotic susceptibility results (implicated platelet bag): acinetobacter baumanii complex susceptibility. Ampicillin + sulbactam: <=4 susceptible. Ceftazidime: 4 susceptible. Ciprofloxacin: <=0. 5 susceptible. Clindamycin: [left blank on report]. Erythromycin: [left blank on report]. Gentamicin: <=2 susceptible. Levofloxacin: < =1 susceptible. Nafcillin: [left blank on report]. Penicillin g: [left blank on report]. Piperacillin + tazobactam: < =8 susceptible. Tetracycline: [left blank on report]. Tobramycin: < =2 susceptible. Trimethoprim sulfamethoxazole bactrim: < =2 susceptible. Vancomycin: [left blank on report]. Staphylococcus saprophyticus susceptibility. Ampicillin + sulbactam: [left blank on report]. Ceftazidime: [left blank on report]. Ciprofloxacin: [left blank on report]. Clindamycin: < =0. 5 susceptible. Erythromycin: < =0. 5 susceptible. Gentamicin: [left blank on report]. Levofloxacin: [left blank on report]. Nafcillin: 0. 5 resistant (predicts resistance to cefazolin). Penicillin g: [left blank on report]. Piperacillin + tazobactam: [left blank on report]. Tetracycline: <=2 susceptible (organisms that are susceptible to tetracycline are also considered susceptible to doxycycline). Tobramycin: [left blank on report]. Trimethoprim sulfamethoxazole bactrim: < =2 susceptible. Vancomycin: 1 susceptible. The saline flushed platelet bag was cultured again and yielded identical results as the initial tests; with a positive result for acinetobacter baumanii complex and staphylococcus saprophyticus. Acinetobacter baumanii complex susceptibility. Ampicillin + sulbactam: <=4 susceptible. Ceftazidime: 4 susceptible. Ciprofloxacin: <=0. 5 susceptible. Clindamycin: [left blank on report]. Erythromycin: [left blank on report]. Gentamicin: <=2 susceptible. Levofloxacin: < =1 susceptible. Nafcillin: [left blank on report]. Penicillin g: [left blank on report]. Piperacillin + tazobactam: < =8 susceptible. Tetracycline: [left blank on report]. Tobramycin: < =2 susceptible. Trimethoprim sulfamethoxazole bactrim: < =2 susceptible. Vancomycin: [left blank on report]. Staphylococcus saprophyticus susceptibility. Ampicillin + sulbactam: [left blank on report]. Ceftazidime: [left blank on report]. Ciprofloxacin: [left blank on report]. Clindamycin: < =0. 5 susceptible. Erythromycin: < =0. 5 susceptible. Gentamicin: [left blank on report]. Levofloxacin: [left blank on report]. Nafcillin: 0. 5 resistant (predicts resistance to cefazolin) penicillin g: [left blank on report]. Piperacillin + tazobactam: [left blank on report]. Tetracycline: <=2 susceptible (organisms that are susceptible to tetracycline are also considered susceptible to doxycycline). Tobramycin: [left blank on report] trimethoprim sulfamethoxazole bactrim: < =2 susceptible. Vancomycin: 1 susceptible. Saline used for flushing implicated platelet bag (din: (b)(4)): on the same date, the (b)(6) laboratory reported negative gram stain and preliminary culture results for samples of the saline used to flush the implicated platelet bag. Final culture results were negative for 15 days. Gram stain results on the co-component indicated? No cells or organisms seen? And were considered final. Co-component (din: (b)(4)): on the same date, the (b)(6) laboratory reported negative gram stain and preliminary negative culture results for samples from the implicated unit? S co-component (din: (b)(4)). Final culture results were negative for 6 days. Gram stain results on the co-component indicated? No organisms seen? And were considered final. On (b)(6) 2018 12:51h, the patient? S central line blood culture report was corrected to reflect a change in the identification of the identified bacteria from gram negative diplococci to acinetobacter baumanii complex. At 15:10h, the patient? S peripheral blood culture report was also corrected to reflect a change from gram negative cocci to gram negative rods isolated. On (b)(6) 2018, central and peripheral samples from the patient were cultured and showed no growth for 2 days. On (b)(6) 2018, further details were provided on the gram stains performed on the samples taken from the platelet bag. Dr. (b)(6) reported the gram stains were positive for numerous (>30/oil immersion field) gram positive cocci in pairs and clusters. No cells were seen in the gram stain. Dr. (b)(6) added that although acinetobacter baumanii is a gram negative bacillus, they are often misidentified as gram positive in gram stains. Dr. (b)(6), the chief of microbiology at (b)(6) further added that acinetobacter baumanii are short, plump, gram negative rods that are difficult to de-stain and may therefore be misidentified as either gram negative or gram positive cocci. Gram stains of acinetobacter baumanii often show predominantly gram positive coccobacilli which were similar in appearance to the gram positive cocci revealed in the sample taken from the implicated platelet bag. Dr. (b)(6) also confirmed that a review of the gram stains from the original product showed? Moderate? Amounts of organisms with this type of morphology present. On the same day, dr. (b)(6) confirmed aerobic culture results from the co-component inocula (by bact/alert instrument) were negative as of 36 hours. Final results were still pending at the time of this report. On (b)(6) 2018, dr. (b)(6) requested that cerus consider testing the staphylococcus isolate for susceptibility to the intercept process in addition to the acinetobacter baumanii isolate, since it was also present in the cultured platelet bag in equivalent amounts. He also noted that the patient received vancomycin during resuscitation before blood cultures were drawn which he posited could explain the lab? S inability to isolate the staphylococcus organism from the patient? S post-transfusion blood cultures. On the same date, the septic reaction was considered by dr. (b)(6) to be transfusion related and was classified as a transfusion transmitted infection. On (b)(6) -2018, dr. (b)(6) reported that a retrograde contamination was unlikely due to the bag being gram stain positive, which suggested a high bacterial load. Per the (b)(6) hospital infection control department, acinetobacter? Positive cultures are fairly unusual at (b)(6) medical center. The last positive isolate was from a blood culture obtained approximately one month prior to the events detailed in this report. The bacterial isolate from the last reported case also had a different antibiotic susceptibility profile compared to the isolate detailed in this report. Colonization and contamination of the blood bag lines was determined to be less likely but could not be ruled out, according to dr. (b)(6). The bags were connected and disconnected from picc line using standard precautions. On 14-may-2018, an update on the (b)(4) investigation from dr. (b)(6) was provided to cerus as follows:? No obvious failure points to the manufacturing process. From production records, it does not appear there was anything awry with the pathogen inactivation (pi) process. The pi process seems to have been successful which leaves two possibilities that fit the findings in the case:? Patient had a pre-existing infection with acinetobacter baumannii or colonization of the picc line through which the platelet was transfused, and retrograde flow at the time of transfusion resulted in the platelet residual being positive for acinetobacter baumannii. " pi treatment was successful, but a breach in product sterility occurred after pi treatment with the positive unit which didn't occur with the co-component.? Dr. (b)(6) also confirmed that (b)(6) records included no evidence that sterility of the involved unit was compromised after intercept treatment. As per standard practice visual inspections at the time of labelling, during storage, and at time of distribution did not indicate any leaks that might have compromised the functional sterility of the intercept-treated product. Dr. (b)(6) noted that the presence of two types of bacteria (acinetobacter baumanni and staphylococcus saprophyticus) in the implicated platelet bag was unusual as this type of finding is more likely indicative of contamination of the sample cultures at the time of sampling. He added that this finding is not consistent with a platelet unit causing a septic transfusion reaction. Dr. (b)(6) noted that the (b)(6) investigation is still ongoing but favored explanation #1 as indicated above. On an unspecified date on the week of (b)(6) 2018, the donor was reported to have visited her dermatologist where her back lesion was swabbed and cultured; results indicated? Mixed skin flora only.? The donor was also noted have traveled to europe on (b)(6) 2018. On 15-may-2018, cerus received an inquiry from dr. (b)(6) regarding the incidence of product quality issues, specifically bag leaks. A formal response was provided on 17-may-2018. On the same date, historical information regarding the patient was provided by dr. (b)(6) and incorporated in the narrative above. Cerus chief medical officer and svp, quality and regulatory affairs discussed this case with bob hunter at the california department of health, who has also approached (b)(6) staff. As of 18-may-2018, the following samples had been received at cerus from (b)(6) medical center. A 5 ml frozen tube taken from the co-component was obtained from (b)(6). A frozen specimen taken from the implicated unit and 5 bacterial isolates that are subbed to nutrient agar slants was obtained from (b)(6). A specimen received frozen from the red cross of the co-component was confirmed to have been intercept treated and illuminated, as residual amotosalen level was at 0. 31 um and the levels of photoproducts were as expected. On (b)(6) 2018, the patient was reported to have been discharged. On 21-may-2018, cerus received a preliminary email report of further testing performed at (b)(6). Tests were conducted on platelet samples collected from (b)(6) on the co-component and on a third saline rinse of the implicated unit taken at an undetermined time subsequent to the reaction. The two platelet specimens and the saline sample were reportedly tested. ? All three samples were amplified for dqa (an hla class ii structural gene), y chromosome, and mitachondrial (mt) dna (73 bp and 1065 bp products). Results from the bsri tests reportedly confirmed successful intercept treatment by demonstrating preferential inhibition of pcr of long length (1065 bp) mt dna compared with short length mtdna (73 bp). The y chromosome test was negative on all samples, while the dqa test showed low concentrations of human dna in the saline flush sample but not in the two co-component samples. The mtdna testing results were reported by bsri director dr. (b)(6), to be? Robust and demonstrates effective pathogen reduction? In both of the co-component samples tested. He added that the sample obtained from the saline rinse of the implicated bag was concentrated by centrifugation so the comparable mtdna levels in both units could be attributed to the concentration steps. The results also revealed the detection of low levels of human genomic dna (dqa dna) in the saline rinse of the implicated bag but not the co-component. Dr. (b)(6) noted this as an oddity since both units were leukoreduced as part of the apheresis collection process. The absence of a y chromosome in these results were thought not to be consistent with a retrograde contamination (the donor is female and the recipient is male) of which further testing as to the sensitivity of the assays are still pending. During a discussion of the results with the bsri team, it was suggested by the cerus chief medical officer, that the positive dqa dna results in the saline flush and not the co-component samples are suggestive of post-production contamination of the implicated pc. If this were donor dna, a positive dqa dna result would be expected with both the co-component and the implicated unit. Until further tests are complete, there is also a possibility that the y chromosome result may be explained by a lower sensitivity assay for this analyte. Bsri staff stated that further investigations will be performed to rule in or rule out post-production contamination before their report is finalized. On 31-may-2018, follow-up information was received from dr. (b)(6) in response to cerus queries. Clarifications on historical data are incorporated into the above narrative and new information is summarized below. Dr. (b)(6) confirmed the assessment for the serious adverse event of transfusion transmitted infection - acinetobacter baumanii [pt: transmission of an infectious agent via product] per the cdc nhsn hemovigilance protocol to be as follows: case definition: definite; severity: life threatening; and imputability: pending further investigation. The transfusion service note shared by dr. (b)(6) summarized that the case was? Highly concerning for a septic transfusion reaction from a contaminated platelet? Due to the acute presentation of septic shock and the presence of acinetobacter baumanii from both the transfused platelet bag and patient? S post-transfusion blood sample in a stable patient when considering the patient? S clinical status prior to the implicated platelet transfusion was afebrile and ready for discharge. It was also indicated in the transfusion note that the patient received vancomycin approximately 2 hours prior to his blood cultures were drawn which could explain why the staphylococcus saprophyticus grew from the implicated platelet bag but not the patient? S blood culture. Possible causes included environmental contamination due to a delay between platelet spiking and sampling resulting in positive platelet bag cultures or retrograde contamination from an infected patient to the bag. Of note, environmental cultures performed at the (b)(6) transfusion service on the platelet incubators and work bench, performed a week after the transfusion reaction and after the surfaces had been disinfected soon after the event, were all negative. The possibility of a retrograde flow was considered to be? Very unlikely? Due to the patients stable clinical status prior to the implicated platelet transfusion, the acute and severe presentation of the reaction, the lack of alternative source (e. G. , no evidence of picc line infection) and the? Limited delay (<7 hrs) in obtaining the initial gram stain from the platelet bag? As well as the large number of organisms identified on the gram stain. In considering the event imputability based on the cdc nhsn hemovigilance protocol, dr. (b)(6)added that one of the criteria listed for the? Definite? Imputability is that no other potential exposures to the pathogen be identified in the recipient which is has proved to be difficult to establish in an immunocompromised patient. He concluded that the imputability is considered pending until investigations are completed. Dr. (b)(6) also indicated that there were 14 acinetobacter baumanii-positive isolates recorded at (b)(6) in 2017 for which susceptibility data is available. On the same date, the microbiology department at cerus reported the preliminary results of the inactivation feasibility studies conducted on the bacterial strains received from (b)(6) on 15-may-2018. The studies revealed inactivation of over ~5 log/ml per fda performance standards of both staphylococcus saprophyticus (>5. 89 log/ml reduction) and acinetobacter baumannii (>5. 95 log/ml reduction), individually and when mixed together (>5. 88 log/ml reduction (s. Saprophyticus) and, >6. 00 log/ml reduction (a. Baumannii )). There was no bacterial growth observed in the tested units at post-illumination, post-cad, or any point up to day 7, indicating inactivation to functional sterility. On 01-jun-2018 a report was received from the (b)(6). Next generation sequencing was performed on three samples from the patient? S blood prior to transfusion ((b)(6)); 3 post-reaction samples ((b)(6)), as well as; a sample from the saline flush of the implicated platelet and two samples from the co-component. The report concluded that? There is evidence of a. Nosocomialis (part of the acinetobacter baumanii complex) in the transfused product and in the post-transfusion patient plasma samples; but minimal to no evidence for this species in pre-transfusion samples or product co-component aliquots (the most recent of which was taken ~10 hours before the septic reaction). There is minimal-to-no evidence of staph. Saprophyticus present in the transfused product aliquot, pre- or post-transfusion patient plasma samples, or product co-component aliquots.? On the same date, additional information on the donor investigation was received from (b)(6) that ongoing attempts are in progress to obtain culture swabs of several areas on the donor. On 03-jun-2018 a report was received from dr (b)(6), chief medical officer of the (b)(6) of studies performed by dr. (b)(6). Growth studies were performed with isolates received from (b)(6) of the implicated s. Saprophyticus and a. Baumanii strains. These studies concluded:? The (b)(6) transfusion reaction workup provided to the (b)(6) indicated that the time to first detection of positivity of the bpa bact/alert bottle from the first saline flush of the implicated bag occurred at 14 hours 41 minutes (the saline flush was reported to have been done through the integral tubing attached to the bag, using sterile docking). Because the time to detection is dependent on the concentration of organisms inoculated into a culture bottle, we performed serial dilutions in saline of separate cultures of the two isolates and used these dilutions to perform both quantitative plate cultures as well as to inoculate bpa bottles, producing a curve relating cfu/ml from the plate cultures to time of first detection of the bact/alert bpa bottles. From the two curves we were able to estimate the concentration of bacteria in the saline flush. For acinetobacter baumannii, the concentration was 4 cfu/ml. For staphylococcus saprophyticus, the concentration was 8 x 103 cfu/ml.? We can conclude from these studies that a. Baumanii, is a rapid growing organism. S. Saprophyticus is a slow growing organism. On (b)(6) 2018, the patient status was reported to have? Recovered? By the director of quality assurance at (b)(6). Reporter assessment: the reporter assessed the event of transfusion transmitted infection - acinetobacter baumanii [pt: transmission of an infectious agent via product] as life-threatening in severity and serious due to being life-threatening. The reporter assessed the causality for the event of transfusion transmitted infection - acinetobacter baumanii [pt: transmission of an infectious agent via product] as definite in relation to the transfused blood product. The reporter also assessed the causality for the event of transfusion transmitted infection - acinetobacter baumanii [pt: transmission of an infe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2018-00004 |
| MDR Report Key | 7575433 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROL MOORE |
| Manufacturer Street | 2550 STANWELL DRIVE L DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9258766819 |
| Manufacturer G1 | CERUS CORPORATION |
| Manufacturer Street | 2550 STANWELL DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Generic Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Product Code | PJF |
| Date Received | 2018-06-06 |
| Model Number | INT2510 |
| Lot Number | CE17C24L61 |
| ID Number | 18717953196924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | 2550 STANWELL DRIVE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-06-06 |