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.
[72417052]
Hvad placed on (b)(6) 2017 complicated by significant intra-op bleeding, vasoplegic/cardiogenic shock, persistent fevers and worsening leukocytosis. Patient with rising ldh since implant. On (b)(6) patient began to have increase in vad flows and frequent power spikes. Taken to operating room on (b)(6) 2017 for emergent vad exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6474964 |
| MDR Report Key | 6474964 |
| Date Received | 2017-04-05 |
| Date of Report | 2017-04-04 |
| Date of Event | 2017-02-26 |
| Date Facility Aware | 2017-02-26 |
| 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 | 2017-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE |
| Manufacturer Address | 500 OLD CONNECTICUT PATH FRAMINGTON MA 01701 US 01701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-04-05 |