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.
[55569282]
Cerus medical assessment: cerus medical reviewer concurs with the reporter's assessment that the event was non-severe and serious due to hospitalization/prolongation of hospitalization. A device malfunction was not reported. However, the cerus medical reviewer does not concur with the reporter's assessment that the event constituted a "suspected septic transfusion reaction", or that is was probably related to the transfusion of intercept platelets. No evidence was provided that the platelet concentrate was contaminated and the fever apparently did not coincide with the transfusion. Patient symptomatology and clinical evolution does not support the presumptive diagnosis of a septic transfusion reaction. Platelet count increment post transfusion does not support it either, and the platelet bags were not cultured or examined. Intercept blood treatment results in greater than or equal to 6. 3 log reduction (cfu/ml) of e. Coli per the approved package insert. Nussbaumer et al. Tested the pathogen inactivation efficacy of the ibs with varying concentrations of seven bacterial species (including e. Coli 1-100 cfus/unit) and found that no bacteria were detected throughout 5 days of storage regardless of the species, level of contamination, and sampling time. Conversely, other sources of infection, such as a urinary tract infection were not ruled out. Lacking evidence of platelet contamination, bacterial isolates or further clinical evidence to support a diagnosis or a suspected septic transfusion reaction, it is concluded that the event was unlikely related to the intercept blood system or the platelet transfusion. Nussbaumer w, allerstorfer d, et al. Prevention of transfusion of platelet components contaminated with low levels of bacteria: a comparison of bacteria culture and pathogen inactivation methods. Transfusion 2007 jul;47(7):1125-33. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55569283]
Case (b)(4) is a spontaneous report received from the medical director at the (b)(6) in (b)(6) on 24-aug-2016, and further communications on the initial report on 28-aug-2016, 31-aug-2016, 05-sep-2016, 08-sep-2016, 14-sep-16, and 15-sep16. The report involves a (b)(6) male caucasian patient, who received intercept platelet components (pc) on (b)(6) 2016 and experienced a serious adverse event described as a suspected septic transfusion reaction with escherichia coli. Concurrent medical conditions included chronic myeloid leukemia (cml). Concomitant medications included glivec (imatinib). Medical history was not reported. On (b)(6) 2016, six whole blood units were collected and used in preparation for a buffy coat pool and treated with the intercept blood system on the following day, (b)(6) 2016. The expiration date of the pc unit was 13-aug-2016. On (b)(6) 2016, the patient received two units of rbc transfusion. On (b)(6) 2016 at 12:27h, the patient received one unit of intercept pc transfusion, 1. 168 x 10883/ 377 ml (pc count/volume) via peripheral line, for bleeding and thrombocytopenia (<50. 10**9/l). At an unspecified time after the pc transfusion, the patient was reported to have experienced fever. Temperature prior and post transfusion was not provided. The action taken with the transfusion was continued. Platelet count prior to transfusion was 18 x 10**9/l and 23 x 10**9/l post transfusion. It was noted that the patient had no evidence of an infection prior to the transfusions. On the same date, two samples from the patient's peripheral blood were taken for testing: one sample taken prior to transfusion at 11:43h and another sample post transfusion at 14:15h. The sample taken prior to transfusion at 11:43h was negative for both aerobe and anaerobe culture. Blood culture from the sample taken post transfusion at 14:15h was positive for gram negative bacillus. On (b)(6) 2016 at 0033h, microbiology test was reported to have confirmed bacterial culture to be escherichia coli. Resistance testing was done (resistant (r)/sensitive (s)): ampicillin (r), amoxicilline/clavu (s), piperacillin/ tazobactam (s), ceftriaxone (s), ceftazidime (s), amikacin (s), ciprofloxacin (s), meropenem (s), colistine (s), cotrimoxazole (s), tigecycline (s). On the same date, the patient was reported to have experienced a serious adverse event of suspected septic transfusion reaction with escherichia coli. The patient's treatment medication included ceftazidime. On (b)(6) 2016, an additional blood culture was performed and was negative for both aerobe and anaerobe culture. On an unspecified date, the patient was reported to have recovered from the event of suspected septic transfusion reaction. 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 noted that the hospital has not observed cases with the same strains in the recent past. The pc bags were not returned to the blood bank and not examined. No samples of bacterial isolates are available for testing and no platelet bags are available for testing. On 08-sep-2016, it was confirmed there were no viable isolates available to be returned to cerus. On 14-sep-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. Reporter assessment: the reporter assessed the event of suspected septic transfusion reaction as non-severe and serious due to 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 was non-severe and serious due to hospitalization/prolongation of hospitalization. A device malfunction was not reported. However, the cerus medical reviewer does not concur with the reporter's assessment that the event constituted a "suspected septic transfusion reaction", or that is was probably related to the transfusion of intercept platelets. No evidence was provided that the platelet concentrate was contaminated and the fever apparently did not coincide with the transfusion. Patient symptomatology and clinical evolution does not support the presumptive diagnosis of a septic transfusion reaction. Platelet count increment post transfusion does not support it either, and the platelet bags were not cultured or examined. Intercept blood treatment results in greater than or equal to 6. 3 log reduction (cfu/ml) of e. Coli per the approved package insert. Nussbaumer et al. Tested the pathogen inactivation efficacy of the ibs with varying concentrations of seven bacterial species (including e. Coli 1-100 cfus/unit) and found that no bacteria were detected throughout 5 days of storage regardless of the species, level of contamination, and sampling time. Conversely, other sources of infection, such as a urinary tract infection were not ruled out. Lacking evidence of platelet contamination, bacterial isolates or further clinical evidence to support a diagnosis or a suspected septic transfusion reaction, it is concluded that the event was unlikely related to the intercept blood system or the platelet transfusion. Nussbaumer w, allerstorfer d, et al. Prevention of transfusion of platelet components contaminated with low levels of bacteria: a comparison of bacteria culture and pathogen inactivation methods. Transfusion 2007 jul;47(7):1125-33.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2016-00006 |
| MDR Report Key | 5975518 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-13 |
| 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 | FENWALL 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 |