MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-06 for PALL EBDS BDS02 manufactured by Haemonetics Corp..
[20356955]
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 had cultured a two platelet unit that was collected and split the collection site from (b)(6) 2013. The collected platelet unit had been tested at the collection site from bacterial contamination using the device prior to splitting and received a pass. The hospital culture on one of the split units grew streptococcus viridans, but the results of that culture were not available prior to the hospital transfusing the one platelet unit. The unit was transfused into a (b)(6) year old male outpatient. The transfusion resulted in a reaction with fever and transfusion lethargy. The recipient then was admitted into the hospital for seven days of antibiotic treatment. The second split unit was sent to a separate facility and transfused on (b)(6) 2013 with no report of bacterial contamination.
Patient Sequence No: 1, Text Type: D, B5
[20498409]
The platelet unit collected on (b)(6) 2013, at the reporting facility was sampled after 24 hours hold and after 18 hour storage at 20-24 degrees celsius. The unit passed using the ebds. The unit was split into two platelet units and both sent to separate hospital locations for transfusion. The reported transfusion reaction was from the platelet unit that tested positive at the hospital lab for streptococcus viridans. A blood culture from the transfusion recipient also grew a culture for streptococcus viridans. This resulted in a transfusion reaction with hospitalization. It is unk at that point the bacteria grew as the ebds testing was performed prior to the unit being split. The second unit was transfused with no reports of bacterial growth or any reaction. The device is not being returned. There are no similar instances reported for the sampling pouch component. The reporting facility states the collected unit was stored and tested appropriately. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219343-2013-00071 |
| MDR Report Key | 3554507 |
| Report Source | 06 |
| Date Received | 2014-01-06 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-26 |
| Date Mfgr Received | 2013-11-26 |
| Date Added to Maude | 2014-01-07 |
| 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 | 7814367209 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL EBDS |
| Product Code | MZC |
| Date Received | 2014-01-06 |
| Catalog Number | BDS02 |
| ID Number | POUCH LOT 1354101 |
| 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 | 0 | 1. Hospitalization | 2014-01-06 |