MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for INTERCEPT BLOOD SYSTEM FOR PLATELETS manufactured by Cerus Corporation.
[55736758]
Cerus medical reviewer concurs with the reporter's assessment that the event of "suspected septic transfusion reaction" was non-severe and serious due to hospitalization/prolongation of hospitalization a device malfunction was not reported. In considering the relatedness of this event to the platelet transfusion the following facts should be taken into account: due to the underlying nature of the disease (i. E. Aml), and the chemotherapy treatment the patient was receiving, it is reasonable to assume that the patient was immunocompromised. A cbc was not made available to the sponsor. The patient had no evidence of an infection prior to the transfusion, but no formal blood culture was taken prior to transfusions. A line culture taken before transfusion was cultured and found to be negative. The patient experienced chills and tachycardia. Temperature increased from 37. 4 degrees celsius to 37. 8 degrees celsius. Chills and tachycardia are suggestive of a febrile non-hemolytic transfusion reaction, although the temperature excursion did not meet the definition of a fever (rise of >1oc) and the patient was not clinically septic. The intercept blood treatment for platelets is highly efficacious to inactivate s. Aureus (greater than or equal to 5. 4 log reduction (cfu/ml)). No specific pathogen inactivation studies have been conducted with staphylococcus haemolyticus but given its similarities with the other species, and the absence of evidence of strain variability in susceptibility to pathogen inactivation, the efficacy of the system against this bacteria is likely comparable. Contamination after pathogen inactivation treatment with the intercept blood system (ibs) but before transfusion cannot be ruled out, but seems unlikely, given the integrity of the closed system and routine inspection of the component during handling. Given these considerations, an alternative explanation for the event the contamination of the platelet product occurred after the sterile integrity of the component was compromised by "spiking" the bag for transfusion, and contamination occurred by retrograde flow from a bacteremia in the patient. However, lacking further information and unavailability of the bacterial isolates for sensitivity testing to the intercept process, failure of the ibs treatment to completely inactivate the bacteria is possible and cannot be ruled out at this time. Incomplete inactivation of bacteria with breakthrough contamination has been reported under experimental conditions where there is delay between collection of the blood product and the performance if the intercept process. Treatment with intercept occurred within 20 hours of collection which is within specification, making it less likely to be a failure. With the current information, the cerus medical assessment is that the patients transfusion reaction is "possibly related" to the transfusion of contaminated platelets that had been treated with the intercept process and failure of the intercept process to completely inactivate the contamination bacteria has not been ruled out. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55736759]
Case (b)(4) is a spontaneous report received on 24-aug-2016, from the medical director at the (b)(6), and further communications on the initial report on 28-aug-2016, 31-aug-2016, 05-sep-2016, 08-sep-2016, 14-sep-2016, and 15-sep-2016. The report involves a (b)(6) year old male patient who received intercept platelet components (pc) on (b)(6) 2016 and experienced a serious adverse event of suspected septic transfusion reaction with staphylococcus haemolyticus. Concurrent medical conditions included acute myeloid leukemia (aml). Concomitant medications included induction therapy daunorubicin, cytosar (cytarabine), langactyl (chlorpromazine hydrochloride), diflucan (fluconazole) and niquitin (nicotine replacement therapy). The patient's medical history was not reported. The patient had no known history of transfusion reactions. On (b)(6) 2016, the patient was admitted in the hospital for elective surgery for placement of a hickman catheter scheduled on (b)(6) 2016. On (b)(6) 2016, six whole blood units were collected with processing times at 17:50h, 16:43h, 16:40h, 17:27h, 17:50h respectively. On (b)(6) 2016 at 10:58h, the whole blood units were used to prepare a buffy coat pool which was centrifuged and fractionated on the maco press system and leukoreduced. The buffy coat pool was treated with the intercept blood system on the same date at 12:59h and the illumination process completed at 13:15h. The expiration date of the pc unit was (b)(6) 2016 on (b)(6) 2016 at 15:45h, the patient received intercept pc transfusion of 1,140 x 10**3/? L 392 ml (pc count/volume) for thrombocytopenia (<50 x10**9/l). Approximately 15 minutes after start of the pc transfusion, the patient experienced chills and tachycardia and the transfusion was discontinued. The patient's body temperature prior to transfusion was 37. 4 degrees celsius and 37. 8 degrees celsius during the transfusion. Blood pressure was 134/68 mmhg prior to transfusion and 136/86 mmhg during transfusion reaction. Heart rate was 98/min prior to transfusion and 109/min during transfusion reaction. Platelet count prior to transfusion was 14x10**9/l and 18x10**9/l post transfusion. The patient had no evidence of an infection prior to the transfusion. On the same date, a sample of the patient's blood catheter taken prior to the transfusion at 03:15h was sent to the microbiology lab for testing. A second sample of the blood catheter was sent to the microbiology lab for testing later in the day at 16:00h. Blood component samples were also taken on the same date at 16:30h and received at the microbiology department at 16:34h. On (b)(6) 2016 at 10:05h, the patient was reported to have experienced a serious adverse event of suspected septic transfusion reaction with staphylococcus haemolyticus. The patient's treatment medication included vancomycin. On an unspecified date, the patient was reported to have recovered from the event of suspected septic transfusion reaction. On (b)(6) 2016, the reporter confirmed that only one isolate from the staphylococcus haemolyticus that was cultured out of the pc is available for evaluation. The isolate out of the patients' blood culture was not stored. Although the pc bag is still available, it has been stored for 14 days in the fridge and subsequent tests were negative for staphylococcus haemolyticus. On (b)(6) 2016, it was reported that the donors were assessed for infections via interview and are unavailable for swabs or tests. Contamination during phlebotomy was deemed to be possible but unlikely. It was also noted that the hospital has not observed cases with the same strains in the recent past. On (b)(6) 2016, it was reported that the isolates from the platelet bag, scheduled to be returned to cerus for testing, was stored and tested for staphylococcus haemolyticus and discarded due to negative results after days 14 of culturing. On (b)(6) 2016, the reporter provided additional reports on the local procedures and the results of the blood component processing with no significant findings. The pathogen inactivation process was also reviewed which showed successful illumination and no indication of malfunction or irregularities. On (b)(6) 2016, analysis report from the samples taken on (b)(6) 2016 was released with the following findings: the sample of the patient's blood catheter taken prior to the transfusion at 03:15h, was negative for both anaerobe and aerobe bacteria. A second sample from the patient's blood catheter taken at16:00h, was positive for staphylococcus haemolyticus for the white lumen but a negative culture for blue lumen. The blood component samples taken at 16:30h was positive for staphylococcus haemolyticus in aerobe culture and in anaerobe culture after enriching the culture with same antibiogram. Resistance testing was done on the strain of staphylococcus haemolyticus (resistant (r)/sensitive (s)): oxacilline (r), tetracyclin (s), gentamicine (r), moxifloxacine (r), erythromycin (r), clindamycin (s),vancomycin (s),cotrimoxazol (r), linezolid (s), and mupirocin (s). Reporter assessment: the reporter assessed the event of suspected septic transfusion reaction as non-severe and serious due to prolonged hospitalization. The reporter indicated the event of suspected septic transfusion reaction to be probably related to the transfusion of intercept treated pcs and not related to device malfunction. Cerus medical assessment: cerus medical reviewer concurs with the reporter's assessment that the event of "suspected septic transfusion reaction" was non-severe and serious due to hospitalization/prolongation of hospitalization a device malfunction was not reported. In considering the relatedness of this event to the platelet transfusion the following facts should be taken into account: due to the underlying nature of the disease (i. E. Aml), and the chemotherapy treatment the patient was receiving, it is reasonable to assume that the patient was immunocompromised. A cbc was not made available to the sponsor. The patient had no evidence of an infection prior to the transfusion, but no formal blood culture was taken prior to transfusions. A line culture taken before transfusion was cultured and found to be negative. The patient experienced chills and tachycardia. Temperature increased from 37. 4 degrees celsius to 37. 8 degrees celsius. Chills and tachycardia are suggestive of a febrile non-hemolytic transfusion reaction, although the temperature excursion did not meet the definition of a fever (rise of >1oc) and the patient was not clinically septic. The intercept blood treatment for platelets is highly efficacious to inactivate s. Aureus (greater than or equal to 5. 4 log reduction (cfu/ml)). No specific pathogen inactivation studies have been conducted with staphylococcus haemolyticus but given its similarities with the other species, and the absence of evidence of strain variability in susceptibility to pathogen inactivation, the efficacy of the system against this bacteria is likely comparable. Contamination after pathogen inactivation treatment with the intercept blood system (ibs) but before transfusion cannot be ruled out, but seems unlikely, given the integrity of the closed system and routine inspection of the component during handling. Given these considerations, an alternative explanation for the event the contamination of the platelet product occurred after the sterile integrity of the component was compromised by "spiking" the bag for transfusion, and contamination occurred by retrograde flow from a bacteremia in the patient. However, lacking further information and unavailability of the bacterial isolates for sensitivity testing to the intercept process, failure of the ibs treatment to completely inactivate the bacteria is possible and cannot be ruled out at this time. Incomplete inactivation of bacteria with breakthrough contamination has been reported under experimental conditions where there is delay between collection of the blood product and the performance if the intercept process. Treatment with intercept occurred within 20 hours of collection which is within specification, making it less likely to be a failure. With the current information, the cerus medical assessment is that the patients transfusion reaction is "possibly related" to the transfusion of contaminated platelets that had been treated with the intercept process and failure of the intercept process to completely inactivate the contamination bacteria has not been ruled out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2016-00007 |
| MDR Report Key | 5975530 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-18 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-09-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROL MOORE |
| Manufacturer Street | 2550 STANWELL DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9258766819 |
| Manufacturer G1 | FENWAL FRANCE SAS |
| Manufacturer Street | ETAILLE, 36-400 |
| Manufacturer City | LA CHATRE, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Generic Name | INTERCEPT PLATELETS |
| Product Code | PJF |
| Date Received | 2016-09-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2016-09-23 |