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 2009-01-09 for PALL BACTERIA DETECTION SYSTEM FOR PLATELET TRANSFUSION PRODUCTS BDS02 manufactured by Ensatec, S.a. De C.v..
[21399377]
It was reported from a blood center that one (1) apparently false negative result was obtained while using the pall bacterial detection device; i. E. An apheresis platelet unit sample was tested for % oxygen and measured within specifications for a pass result. This apheresis unit was split into two products and sent to two different facilities. First split unit was sent to a transfusion facility that maintains an sop directing the culture of a sample of each platelet product when issued for transfusion. As such, the 1st split unit sample was cultured and tested positive for strep viridans. The 2nd split unit had been sent from the blood center to a different transfusion facility that does not routinely culture samples of platelets prior to transfusion. Both platelet product split units were administered to different patients, one at each transfusion, and no transfusion reactions were reported from either facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617787-2009-00006 |
| MDR Report Key | 1282104 |
| Report Source | 05,06,07 |
| Date Received | 2009-01-09 |
| Date of Report | 2008-12-30 |
| Date of Event | 2008-12-29 |
| Date Facility Aware | 2008-12-30 |
| Report Date | 2008-12-30 |
| Date Reported to Mfgr | 2008-12-30 |
| Date Mfgr Received | 2008-12-30 |
| Date Added to Maude | 2009-09-01 |
| 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 | DR. LEONARD BERMAN |
| Manufacturer Street | 25 HARBOR PARK DR |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5168019183 |
| Manufacturer G1 | ENSATEC, S.A. DE C.V. |
| Manufacturer Street | FRACCIONAMIENTO EL FLORIDO CALLE COLINAS #11730 |
| Manufacturer City | TIJUANA, B.C.,, 22680 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22680 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL BACTERIA DETECTION SYSTEM FOR PLATELET TRANSFUSION PRODUCTS |
| Generic Name | BACTERIA DETECTIN SYSTEM |
| Product Code | MZC |
| Date Received | 2009-01-09 |
| Model Number | BDS02 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENSATEC, S.A. DE C.V. |
| Manufacturer Address | FRACCIONAMIENTO EL FLORIDO CALLE COLINAS #11730 TIJUANA, B.C.,, 22680 MX 22680 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-09 |