MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-02 for HEART MATE II VAD 19241 manufactured by Abbott.
[67114488]
Pump malfunction vs pump thrombosis. Elevated pump power with elevated flows, elevated ldh; pt emergently taken to operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6315467 |
| MDR Report Key | 6315467 |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-25 |
| Date Facility Aware | 2017-01-25 |
| Report Date | 2017-02-01 |
| Date Added to Maude | 2017-02-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | 0 |
| Brand Name | HEART MATE II |
| Generic Name | LVAD, OKR |
| Product Code | OKR |
| Date Received | 2017-02-02 |
| Model Number | VAD 19241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-02-02 |