MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2004-09-29 for PALL EBDS BDS02/400-03 NA manufactured by Pall Medsep.
[363407]
It was reported that the device (the pall bds oxygen analyzer) tested a platelet, apheresis unit as a false negative for bacteira. The unit was tested and then split into two (2) products (see also 2013342-2004-00007). The two (2) products were distributed and transfused to two (2) defferent patients. Both patients had an increase in temperature and pulse. They also experienced chills. The units were suspected to be contaminated with bacteria.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013342-2004-00006 |
| MDR Report Key | 546988 |
| Report Source | 04,05,06 |
| Date Received | 2004-09-29 |
| Date of Report | 2004-09-03 |
| Date of Event | 2004-08-27 |
| Date Facility Aware | 2004-08-27 |
| Report Date | 2004-09-03 |
| Date Reported to FDA | 2004-09-03 |
| Date Reported to Mfgr | 2004-09-03 |
| Date Mfgr Received | 2004-09-20 |
| Date Added to Maude | 2004-10-05 |
| 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 | LEONARD BERMAN, PH.D. |
| Manufacturer Street | 2200 NORTHERN BOULEVARD |
| Manufacturer City | EAST HILLS NY 11548 |
| Manufacturer Country | US |
| Manufacturer Postal | 11548 |
| Manufacturer Phone | 5164845400 |
| Manufacturer G1 | PALL MEDSEP |
| Manufacturer Street | 1630 INDUSTRIAL PARK ST. |
| Manufacturer City | COVINE CA 91722 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL EBDS |
| Generic Name | BACTERIAL DETECTION SYSTEM FOR PLATELET TRANSFUSION PRODUCTS |
| Product Code | MZC |
| Date Received | 2004-09-29 |
| Model Number | BDS02/400-03 |
| Catalog Number | NA |
| Lot Number | L/N 0400995 |
| ID Number | C,1.00 VAL009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1.3 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536396 |
| Manufacturer | PALL MEDSEP |
| Manufacturer Address | * COVINA CA * US |
| Baseline Brand Name | PALL EBDS |
| Baseline Generic Name | BACTERIAL DETECTION SYSTEM FOR PLATELT TRANSFRUSION PRODUCTS |
| Baseline Model No | BDS02/400-03 |
| Baseline Catalog No | NA |
| Baseline ID | C, 1.00 VAL009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-09-29 |