MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-02-02 for BACT BPA * manufactured by Biomerieux, Inc..
[15214845]
The bact alert bpa bottle is a standard aerobic blood culture bottle used to monitor microbial (bacteria and fungi) growth. The customer complaint was that they tested a random platelet unit and it was negative at 5 days. Following this result, the unit was transfused and the patient had an immediate reaction. Upon investigation, it was unknown how much of the unit was transfused. In addition how old the unit was at the time of transfusion is also unknown. The unit was cultured and blood cultures drawn on the patient (x3). All of the samples had presence of staph chromogenes. It was also not known if the contaminant was introduced when the bottle was innoculated. There has been no additional updates of any other additional medical internvention or adverse reaction regarding this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2006-00036 |
| MDR Report Key | 673543 |
| Report Source | 07 |
| Date Received | 2006-02-02 |
| Date of Report | 2006-01-17 |
| Date of Event | 2005-10-12 |
| Date Mfgr Received | 2005-10-12 |
| Date Added to Maude | 2006-02-14 |
| 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 | NANCY OLSCAMP, SR. SPECIALIST |
| Manufacturer Street | 100 RODOLPHE ST. |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196202879 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT BPA |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2006-02-02 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | 279018 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 662853 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-02-02 |