MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-05 for HEARTWARE manufactured by Heartware.
[72434789]
Hvad placed (b)(6) 2017 s/p hvad pump exchange on (b)(6) 2017. Hospital course c/b intra-op bleeding, cardiogenic shock, and leukocytosis. Continued to have rising ldh and bili s/p exchange. Increased vad flows and watts, tee with concerns for high velocity at outflow cannula. Taken to operating room for vad exchange on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6474966 |
| MDR Report Key | 6474966 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-02 |
| Date Facility Aware | 2017-03-02 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Added to Maude | 2017-04-10 |
| 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 | HEARTWARE |
| Generic Name | HVAD |
| Product Code | OKR |
| Date Received | 2017-04-05 |
| Returned To Mfg | 2017-03-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGHAM MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-04-05 |