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.
[72367163]
Patient with hvad implant on (b)(6), s/p pump exchange on increase and suspicion of pump thrombus. Hospital course c/b cardiogenic shock, increased pressor requirements, aki requiring cvvh. Pump flow and power increases again on (b)(6). On (b)(6) 2017, at request of family, withdrawal of all forms of support including vasopressors/inotropes, lvad and icd. Cause of death, lvad thrombosis leading to cardiac arrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6474967 |
| MDR Report Key | 6474967 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-03-05 |
| Date Facility Aware | 2017-03-05 |
| 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 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 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. Death; 2. Hospitalization | 2017-04-05 |