MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for BERLIN HEART EXCOR VAD P10P 10M manufactured by Berlin Heart.
[41981235]
Perfusion was priming berlin heart excor vad (p10p 10m #(b)(4)) and discovered plastic in the valve of the heart which could not be removed through priming. Therefore a second backup berlin heart was primed and used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061459 |
| MDR Report Key | 5546856 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-03-18 |
| Date Added to Maude | 2016-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | BERLIN HEART EXCOR VAD |
| Generic Name | BERLIN HEART EXCOR VAD |
| Product Code | PCK |
| Date Received | 2016-04-01 |
| Model Number | P10P 10M |
| Lot Number | 1320554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERLIN HEART |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |