MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-05-25 for BACT/ALERT - BPA BOTTLE 279018 NA manufactured by Biomerieux, Inc..
[21702128]
In 2007, blood center collected whole blood derived donor platelets. On the same day, an aliquot of the platelet unit was incubated at 37 degree c for 24 hours post-collection. The following day, a bact/alert bpa bottle (lot 10105093, exp. 12/12/07) was inoculated with the incubated aliquot. Four days later, a transfused patient was reported to have "suspected bacteremia". The patient developed a post-transfusion infection with group d strep resulting in the pt's death. The date of the pt's death is unknown at this time. The transfusion occurred at cancer and research center using platelets from blood center, but the exact date of transfusion is unknown at this time. According to blood center, the bpa bottle underwent 5 day testing and generated a negative result. The bottle was discarded so additional testing is not possible.
Patient Sequence No: 1, Text Type: D, B5
[21802231]
The sampling protocol followed by blood center (bc) does not comply with the platelet specimen collection procedures detailed in the bact/alert bpa (bpa) package insert. The bpa package inserts reads "the platelet specimen should be taken at least 24 hours after collection to allow for natural proliferation in the platelet product". As noted in the package insert, the platelet specimen should be stored at room temperature (15-30 degree c) during the 24 hours post-collection. Although the fbc's sampling protocol does not follow the bpa package insert procedures, it has been approved by fda according to fbc's medical director. Fbc believes that incubation at 37 degree c is better than storing at room temperature for organism proliferation. Since platelets must remain at room temperature for transfusion, the entire platelet unit cannot be incubated at 37 degree c. For this reason, fbc retrieved an aliquot after sample collection to incubate at 37 degree c for 24 hours and then inoculated the bpa bottle. This poses an issue because the number of organisms in the aliquot is not representative of the number of organisms in the entire platelet unit. Since the number of organisms in donor platelet units are typically low, an aliquot is not likely to contain a viable number of organisms even though the non-incubated, transfused portion unit may contain a viable number of organisms for detection. Also, cancer ctr tested the platelet unit using bpa (per the package insert instructions) after the pt was diagnosed with "suspected bacteremia" and rec'd a positive result. The positive result obtained by cancer ctr shows that the bpa bottle, when used as instructed, detects organisms properly. The negative result obtained by bc was due to their sampling methodology differing from the bact/alert bpa package insert instructions. Biomerieux obtained back-up disks from bc to review the performance of the instrument and was unable to detect any errors associated with this negative result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2007-00003 |
| MDR Report Key | 856840 |
| Report Source | 05,06,07 |
| Date Received | 2007-05-25 |
| Date of Report | 2007-05-09 |
| Date of Event | 2007-04-30 |
| Date Added to Maude | 2007-09-11 |
| 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 | NIKITA MAPP |
| Manufacturer Street | 595 ANGLUM |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317474 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT - BPA BOTTLE |
| Generic Name | MICROBIAL DETECTION SYSTEM |
| Product Code | LTT |
| Date Received | 2007-05-25 |
| Model Number | 279018 |
| Catalog Number | NA |
| Lot Number | 1015093 |
| ID Number | NA |
| Device Expiration Date | 2007-12-31 |
| 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 | 883498 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | HAZELWOOD MO 63042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-05-25 |