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 61902 manufactured by Abbott.
[67114835]
Pump malfunction vs pump thrombosis. Pt underwent lvad placement on (b)(6) 2017 as destination therapy; developed hypotension; on pressor support. Elevated lactic acid; pt taken emergently to operating room for pump exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6315485 |
| MDR Report Key | 6315485 |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-01-28 |
| Date Facility Aware | 2017-01-28 |
| 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 | 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 | 0 |
| Brand Name | HEART MATE II |
| Generic Name | LVAD |
| Product Code | OKR |
| Date Received | 2017-02-02 |
| Model Number | VAD 61902 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2017-02-02 |