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.
[17267377]
Admitted low flow alarms, increased symptoms heart failure, tea colored urine, elevated ldh and creatinine. Speed change echo showed persistant pulse at 12,000 rpm suggestive of pump thrombosis. Device exchanged and thrombus noted within pump around bearing site. Right hemicolectomy due to ischemia.
Patient Sequence No: 1, Text Type: D, B5
[17524223]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 4492198 |
| MDR Report Key | 4492198 |
| Report Source | * |
| Date Received | 2015-02-06 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-11-27 |
| 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 | 265 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 |