MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-06-02 for PALL EBDS BDS02 manufactured by Haemonetics Corp.
[46432225]
The platelet unit collected at the reporting facility was sampled and stored appropriately according to the facility protocols. The unit passed bacterial testing using the ebds bacterial detection system on (b)(6) 2016 on the mother platelet storage bag. The platelet unit was tested at the hospital microbiology lab after the transfusion reaction and was positive for staphylococcus aureus. The device is not being returned. There was no platelet sample returned to haemonetics for testing. Staphylococcus aureus should have been detected by the ebds if the test was performed correctly, but in mitigation, if the sampling was conducted at a time when the bacteria in the mother platelet storage bag had not grown sufficiently to be captured in the ebds pouch during the sampling process, or the incubation period/conditions were not correct, then the level for detection by the ebds was not reached. There are other possible points in the splitting into daughter platelet bags and transfusion preparation process that could have been the cause of the contamination. The root cause is inconclusive as no samples were returned for evaluation. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[46432226]
Haemonetics received a complaint that the pall enhanced bacterial detection system (pall ebds) returned a false negative result which resulted in a transfusion reaction. It was reported to haemonetics that a hospital end-user transfused one unit of platelets to a patient receiving chemotherapy for relapsed ph+ acute lymphoblastic leukemia. The collected platelet unit had been tested at the collection site for bacterial contamination using the ebds device. The test did not detect bacterial growth. No testing was done at the hospital prior to transfusion. The transfusion resulted in a reaction with fever, chest tightness, dyspnea, back pain, flank pain and nausea. The transfusion was stopped and a transfusion reaction workup initiated; ua and blood cultures sent as well as bb samples. The patient has no prior history of reactions. The patient required additional medical intervention with antibiotic treatment receiving daptomycin, oxacillin, and clindamycin in addition to vancomycin which was prescribed pre-transfusion. The patient developed septic shock which subsequently resolved and all blood cultures are negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2016-00037 |
| MDR Report Key | 5695358 |
| Report Source | USER FACILITY |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-03 |
| Date of Event | 2016-05-02 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2016-06-02 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL EBDS |
| Generic Name | SYSTEM,DETECTION,BACTERIAL, FOR PLATELET TRANSFUSION PRODUCTS |
| Product Code | MZC |
| Date Received | 2016-06-02 |
| Model Number | BDS02 |
| Catalog Number | BDS02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORP |
| Manufacturer Address | 400 WOOD RD BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 400 | 1. Hospitalization | 2016-06-02 |