MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-12-09 for BACT/ALERT BPA AND BPN CULTURE BOTTLES 279018 279019 manufactured by Biomerieux, Inc..
[2719866]
A recipient at the (b)(6) in (b)(6), received a partially transfused platelets pheresis unit and experienced severe dyspnea and an elevated temperatures of 40 degrees c.
Patient Sequence No: 1, Text Type: D, B5
[9860895]
An investigation of this incident has been initiated by biomerieux inc. The community blood center initiated a transfusion reaction investigation on (b)(6) 2008. The report stated that "the implicated unit was collected on (b)(6) 2008 and sterility sampling was performed on (b)(6) 2008. The bact/alert bottles remained negative and were removed from the incubator on (b)(6) 2008. The aerobic and anaerobic bottles along with the associated fresh frozen plasma unit were sent to the reference lab for cultures; no bacterial growth was detected. " "the gram stain and culture from the partially transfused platelet product showed gram positive cocci and the culture grew (b)(6). " "investigation reveals the bact/alert system for notification was functioning and review by the fda indicated that all standard operating procedure had been followed. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00009 |
| MDR Report Key | 2576515 |
| Report Source | 05,06 |
| Date Received | 2008-12-09 |
| Date of Report | 2008-12-03 |
| Date of Event | 2008-10-14 |
| Date Mfgr Received | 2008-11-11 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2012-05-21 |
| 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 | ELIZABETH FRITZ |
| Manufacturer Street | 100 RODOLPHE ST |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202682 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT BPA AND BPN CULTURE BOTTLES |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-12-09 |
| Catalog Number | 279018 279019 |
| Lot Number | 1020387 1020417 |
| Device Expiration Date | 2009-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-12-09 |