MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-22 for INTERCEPT BLOOD SYSTEM FOR PLATELETS INT2204B manufactured by Cerus Corporation.
[48008887]
Cerus medical assessment: cerus medical reviewer assesses this event as possibly related to the transfusion infection, but unlikely related to the intercept blood system. Laboratory confirmation of the alleged septic event is outstanding and there is insufficient evidence to confirm a relationship with an intercept platelet transfusion. No device malfunction was reported and reporter acknowledged failure to follow approved instructions for use for the intercept blood system for platelets. Latest assessment provided by reporter does not reasonably suggest or allege that the device may have caused or contributed to the event. It also does not reasonably suggest or allege that the device failed to meet its performance specification. No details have been provided on the process that was followed to split the buffy coat unit into the pediatric doses. B. Cereus contamination could have occurred at that moment this pathogen is widely distributed environmentally. Further information is needed from the reporter on the donor, the patient and the platelet components. Reporter advised cerus that "no further action is required regarding this matter unless advised by us. "
Patient Sequence No: 1, Text Type: N, H10
[48008888]
Case (b)(4) is a spontaneous report received from the director of the blood bank at (b)(6)hospital and research centre on (b)(6) 2016, and further communications on the initial report received on 25-may-2016, 08-jun-2016, 09-jun-2016 and 12-jun-2016. The report involves a (b)(6) old female patient who received intercept treated platelet components (pc) from (b)(6) 2016 and experienced an adverse event of bacillus cereus bacterial infection suspected to have been transmitted by platelet transfusion. Concurrent medical condition includes acute myeloid leukemia. Concomitant medications and medical history were not reported. On an unspecified date in (b)(6) 2016, a buffy coat platelet pool was prepared from five donors and split into three pediatric doses which were treated with the intercept blood system. The (b)(6) old female patient was one of three pediatric patients who received transfusions derived from the pooled buffy coat pc's from (b)(6) 2016. On an unspecified date following pc transfusion, these three patients were reported to have tested positive for bacillus cereus. The reporter also noted that one platelet bag was cultured post transfusion which was positive for bacillus cereus. It was unspecified whether this platelet bag was the one used in the pc transfusion received by the (b)(6) old female patient. On (b)(6) 2015, the reporter mentioned to a cerus employee, within the scientific affairs department, of being in the process of investigating an "outbreak" of bacillus cereus bacterial infection possibly transmitted by platelet transfusion to three patients who received intercept treated pc. On (b)(6) 2015, in response to query, the reporter added that a similar incident occurred 10 months ago, in which three pediatric patients were reported to be positive for bacillus cereus post intercept platelet transfusion. However, in these cases, the platelet bag was unavailable for testing and unable to confirm presence of bacteria in the pc. The reporter also provided a copy of the illuminator treatment report, with a treatment start date of (b)(6) 2016, which showed successful illumination. On 26-may-16, 31-may-16 and 08-jun-2016, additional information was requested from the initial reporter regarding the adverse event of bacillus cereus bacterial infection suspected to have been transmitted by platelet transfusion. On 07-jun-2016, a cerus employee within the deployment department was present at the (b)(6) hospital blood bank in the context of an routine customer support visit. During this visit, the cerus employee was made aware of the reported adverse events of bacillus cereus bacterial infection transmitted by platelet transfusion that was initially reported on (b)(6) 2016 and proposed a verification of good practices at the blood bank. The cerus employee observed that the blood bank operators deviated from instructions for use (ifu) for the intercept processing set for large volume platelet units by not mixing the platelets with amotosalen (s-59) sufficiently, specifically by not flushing back a mixture platelets and s59 in the tubing and leaving the 4cm segment of tubing filled with platelets mixed with s-59. The time between disconnecting the pc and s-59 pack assembly from the illumination pack to load onto the illuminator was also shorter than expected (less than 1 minute). Additionally, non-compliance with good manufacturing practice (gmp) with regard to the production flow was observed in that the pre and post illumination production steps overlapped; the process of transferring platelet and s-59 to the illumination pack (processing step b) and the step to transfer the illuminated platelets into the cad is done in the same area. The cerus employee concluded that the likelihood of poor exposure of pc with amotosalen, at the time of illumination, is very high. The cerus employee also observed that the preventative maintenance for the illuminator, which includes calibration, did not occur at the scheduled interval of (b)(6) 2016. It was also noted that the operators acknowledged their mistake and the observations were shared with the initial reporter, the director of the blood bank at (b)(6) hospital and research centre. On (b)(6) 2016, the initial reporter confirmed meeting with the cerus employee and noted that some fine tuning for the pathogen inactivation process was performed and recommendations for corrective actions were implemented immediately. On 10-jun-2016, additional information was again requested from the initial reporter regarding the adverse event of bacillus cereus bacterial infection transmitted by platelet transfusion. On (b)(6) 2016, the reporter informed cerus that the matter was still under investigation. Currently, the findings are inconclusive and they are "not sure of the source or whether it is related to pathogen inactivation or not. " the reporter advised cerus that "no further action is required regarding this matter unless advised by us. " reporter assessment: the reporter did not provide a severity or seriousness assessment for the events of bacillus cereus bacterial infection transmitted by platelet transfusion. The imputability rating was interpreted to be possibly related for the event. Cerus medical assessment: cerus medical reviewer assesses this event as possibly related to the transfusion infection, but unlikely related to the intercept blood system. Laboratory confirmation of the alleged septic event is outstanding and there is insufficient evidence to confirm a relationship with an intercept platelet transfusion. No device malfunction was reported and reporter acknowledged failure to follow approved instructions for use for the intercept blood system for platelets. Latest assessment provided by reporter does not reasonably suggest or allege that the device may have caused or contributed to the event. It also does not reasonably suggest or allege that the device failed to meet its performance specification. No details have been provided on the process that was followed to split the buffy coat unit into the pediatric doses. B. Cereus contamination could have occurred at that moment this pathogen is widely distributed environmentally. Further information is needed from the reporter on the donor, the patient and the platelet components. Reporter advised cerus that "no further action is required regarding this matter unless advised by us. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2016-00004 |
| MDR Report Key | 5743584 |
| Date Received | 2016-06-22 |
| Date of Report | 2016-06-22 |
| Date of Event | 2016-05-13 |
| Date Mfgr Received | 2016-05-24 |
| Date Added to Maude | 2016-06-22 |
| 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 | 2016-06-22 |
| Model Number | INT2204B |
| Lot Number | CE15J14L62 |
| 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. Other | 2016-06-22 |