FDA Adverse Event
Injury
Summary report: N
BERLIN HEART EXCOR PEDIATRIC VAD
MDR report key: 7451862
·
Received April 23, 2018
Report
- Report Number
- 3004582654-2018-00016
- Event Type
- Injury
- Date Received
- April 23, 2018
- Date of Event
- April 8, 2018
- Report Date
- April 23, 2018
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- PMA / PMN Number
- P160035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE PATIENT REMAINS ON SUPPORT. G8: ADVERSE EVENT TERM: EMBOLISM.
Description of Event or Problem · 0
THE SITE CONTACTED BERLIN HEART (B)(4) CLINICAL AFFAIRS TO REPORT THAT A PATIENT SUPPORTED BY AN EXCOR BLOOD PUMP IN THE BVAD CONFIGURATION THAT DURING THE NIGHT OF (B)(6) 2018 THAT THROMBUS FROM THE RVAD PUMP DISLODGED IN THE LEFT LUNG, LEADING TO A LUNG EMBOLISM. THE SITE INCREASED VENTILATOR SUPPORT AND STARTED NO TREATMENT. SITE MANAGED TO WEAN ALMOST TO BASELINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295083 | BERLIN HEART EXCOR PEDIATRIC VAD | VENTRICULAR ASSIST DEVICE | DSQ | BERLIN HEART GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 DA | Life Threatening |