MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-11 for RESERVIOR manufactured by Medtronic, Inc..
[96959900]
Patient Sequence No: 1, Text Type: N, H10
[96959901]
During cardiopulmonary bypass, clot was noticed in the venous reservoir in an isolated ring pattern. Surgeon was advised to complete operation as quickly as possible and get off bypass. No other clots were noticed in the circuit and the equipment was sequestered. Manufacturer was notified. ====================== manufacturer response for reservoir, reservoir (per site reporter) ====================== not known.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7181879 |
| MDR Report Key | 7181879 |
| Date Received | 2018-01-11 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-12-20 |
| Report Date | 2017-12-22 |
| Date Reported to FDA | 2017-12-22 |
| Date Reported to Mfgr | 2017-12-22 |
| Date Added to Maude | 2018-01-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESERVIOR |
| Generic Name | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Product Code | DTN |
| Date Received | 2018-01-11 |
| Lot Number | 214093041 |
| ID Number | BB8E47R17 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-11 |