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 2014-04-28 for PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX manufactured by Teleflex Medical.
[4366169]
Complaint alleges: during a re-infusion procedure, the rns (registered nurses) said they squeezed the bags repeatedly but the blood did not seem to flow. The bags filled easily, but they had trouble getting the blood out of the bag. Additional information received: the pt was getting transfused due to acute blood loss from a gunshot wound to the chest. The pt is deceased. The medical interventions performed were: chest thoracotomy, blood transfusions, chest tube, iv fluids.
Patient Sequence No: 1, Text Type: D, B5
[11892525]
The device history record has been reviewed and no issues or discrepancies were found, which could potentially relate to this complaint. No rejection report was originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. A history review was conducted for similar complaints for catalog #s-250-08, and no previous complaints were found that relate to the reported issue. Device sample received by manufacturer, but investigation is still underway at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00164 |
| MDR Report Key | 3804453 |
| Report Source | 05,06,07 |
| Date Received | 2014-04-28 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2014-05-13 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX |
| Generic Name | TRANSFER BAG |
| Product Code | PAD |
| Date Received | 2014-04-28 |
| Returned To Mfg | 2014-04-15 |
| Lot Number | 02G1202875 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-04-28 |