MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-15 for BACT/ALERT BPA CULTURE BOTTLE 279018 manufactured by Biomerieux, Inc..
[20891171]
The customer reported that three pts became ill after a platelet transfusion and gram-positive cocci in clusters were found in pt. The customer incident report stated that the platelet bag was split for three transfusions and held for 24 hours. A sample was taken from one unit for incubation in the bact/alert bpa culture bottle. The platelets were released after 12 hours of incubation and transfused to three pts who became ill. Bact/alert bpa culture bottles are used with the bact/alert microbial detection systems for quality control testing of leukocyte reduces apheresis platelet (lrap) units, and both leukocyte reduces single and pooled whole blood platelet concentrates (wbpc). Bact/alert bpa bottles support the growth of aerobic microorganisms ( bacteria and fungi).
Patient Sequence No: 1, Text Type: D, B5
[21122719]
An investigation has been opened on this mdr. According to the customer, the bact/alert bpa culture bottle was negative after 5 days; the bottle indicator showed no change in color. The bact/alert bpa bottle was sent for culture, and the customer reported that the gram stain showed no organism, and that the culture was negative for growth after 48 hours. The package insert for the bactalert bpa bottle 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-innoculation 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. " the package insert also recommends that "bact/alert bpa... Culture bottles should be inoculated from the platelet specimen for optimal recovery of contaminating organisms. For best overall recovery when culturing platelet specimens, it is strongly recommended that more that one type of culture bottle be utilized (e. G. , one aerobic and one anaerobic. )
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2008-00001 |
| MDR Report Key | 1003517 |
| Report Source | 05,06 |
| Date Received | 2008-02-15 |
| Date of Report | 2008-02-14 |
| Date of Event | 2008-01-16 |
| Date Mfgr Received | 2008-01-16 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2008-11-12 |
| 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 CULTURE BOTTLE |
| Generic Name | MICORBIAL GROWTH MONITOR |
| Product Code | JTA |
| Date Received | 2008-02-15 |
| Catalog Number | 279018 |
| Lot Number | 1018544 |
| Device Expiration Date | 2008-10-31 |
| 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 | 1001594 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 100 RODOLPHE ST DURHAM NC 27712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-02-15 |