MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for CENTRIMAG RVAD 20155082001 102953 manufactured by Thoratec.
[51498686]
Patient Sequence No: 1, Text Type: N, H10
[51498687]
Patient had both an hm ii lvad implant and centrimag rvad implant. Daily assessments of centrimag rvad cannulas revealed known small area on inflow cannula just outside the pump that was suspicious for fibrin clot. A month after implantation, the suspicious area on the inflow cannula was no longer seen but the outflow cannula revealed an area of clot that had extended from approx. 4 inches from pump to approx. 2 feet of cannula. The team was immediately notified and the rvad pump and rvad inflow and outflow external cannulas were replaced at the bedside. At time of event, patient was receiving bival @0. 082mg/kg/hr and full strength asa with last ptt 76. 4. Following the cannula exchange, patient also started on persantine 75mg tid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856218 |
| MDR Report Key | 5856218 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-07-27 |
| Report Date | 2016-08-02 |
| Date Reported to FDA | 2016-08-02 |
| Date Reported to Mfgr | 2016-08-02 |
| Date Added to Maude | 2016-08-09 |
| 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 | 0 |
| 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 | CENTRIMAG RVAD |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2016-08-09 |
| Model Number | 20155082001 |
| Catalog Number | 102953 |
| Device Availability | * |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC |
| Manufacturer Address | 6035 STONERIDGE ROAD PLEASANTON, CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-09 |