MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-02-06 for HEARTMATE II LVAS manufactured by Thoratec Corporation.
[5327528]
Patient had possible prolonged pump off time. Patient presented to clinic with signs of hemolysis (elevated ldh). Pump support was withdrawn on (b)(6) 2014 due to elevated powers. Patient expired (b)(6) 2014. Providers at home state that controller never alarmed to the power depletion of pump off.
Patient Sequence No: 1, Text Type: D, B5
[12965654]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 4492450 |
| MDR Report Key | 4492450 |
| Report Source | * |
| Date Received | 2015-02-06 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-04-11 |
| Date Facility Aware | 2015-01-05 |
| Report Date | 2015-02-06 |
| Date Reported to FDA | 2015-02-06 |
| Date Reported to Mfgr | 2015-02-06 |
| Date Added to Maude | 2015-02-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE II LVAS |
| Generic Name | LVAD |
| Product Code | OKR |
| Date Received | 2015-02-06 |
| Device Age | 156 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-02-06 |