MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-04 for PALL EBDS BDS02 manufactured by Haemonetics Corp..
[4632126]
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 acute myeloid 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 a rash, pruritus, flushing chills and nausea. The transfusion was terminated as soon as the reaction was evident. The patient received benadryl and ativan. The symptoms subsided with the administration of the medication.
Patient Sequence No: 1, Text Type: D, B5
[12218219]
The platelet unit collected on 06/03/2014 at the reporting facility was sampled and stored appropriately according to the facility protocols. The unit passed bacterial testing using the ebds. The platelet unit was tested at the hospital after the transfusion reaction and was positive for staphylococcus epidermidis and staphylococcus hominis. The ebds does not detect staphylococcus hominis. The device is not being returned. The platelet sample was returned to the manufacturing site. Results are not available at the time of this report. A supplemental report will be filed when the results become available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219343-2014-00022 |
| MDR Report Key | 3984613 |
| Report Source | 06 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-05 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD. |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL EBDS |
| Product Code | MZC |
| Date Received | 2014-08-04 |
| Catalog Number | BDS02 |
| ID Number | POUCH LOT: 1454023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 0 | 1. Hospitalization | 2014-08-04 |