MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-06 for BACT/ALERT BPA AND BPN CULTURE BOTTLES 279018 manufactured by Biomerieux, Inc..
[15165703]
Two patients suffered septic transfusion reactions following contaminated platelet transfusions. Bactalert bpn and bpa were negative-to-date on day 4 at the time of the transfusion. The apheresis donation was split and transfused into two patients. Patient 1 experienced transfusion reaction the evening of the transfusion. Blood cultures from patient and cultures from the platelet bags were performed. Methicillin-resistant s aureus was recovered from both the patient and the platelet bags. Two days after the transfusion, septic transfusion reaction was reported in the second patient. The bpn and bpa bottles were still under test and negative-to-date (day 6). When the bpn and bpa bottles reached maximum test time, they were still negative. The bottles were sent to the microbiology lab for testing; the gram-stains showed no organisms and the subcultures had no growth. Both patients who had reactions recovered and were discharged from hospital.
Patient Sequence No: 1, Text Type: D, B5
[15168962]
Add'l lot# 1016995, exp date: 05/31/08. The medical director of the lab where the event occurred does not allege any defect or failure on the part of bact/alert or the bpn or bpa bottles used in testing and believes the organism was so low in the donated unit that no viable organisms were captured in the 4-8 ml/bottle sample. Package inserts for both bpa and bpn bottles state "after culture bottle have been loaded into the instrument, they should remain there for five to seven days or until designated positive, or until the platelet unit reaches its expiration date. " the package insert also cautions that "a report of 'negative' should not be interpreted as meaning that the original product is sterile. The negative status could be due to under-inoculation of the bottle, no organisms present in the inoculum, the number of organisms were too small for detection, or a culture bottle/medium that does not support the growth of the organism. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2007-00006 |
| MDR Report Key | 948532 |
| Report Source | 05,06 |
| Date Received | 2007-11-06 |
| Date of Report | 2007-11-05 |
| Date of Event | 2007-10-16 |
| Date Mfgr Received | 2007-10-16 |
| Device Manufacturer Date | 2007-08-02 |
| Date Added to Maude | 2008-01-15 |
| 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 | 2007-11-06 |
| Catalog Number | 279018 |
| Lot Number | 1017756 |
| Device Expiration Date | 2008-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 943616 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 ROLDOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-06 |