FDA Adverse Event
Injury
Summary report: N
BERLIN HEART EXCOR PEDIATRIC VAD
MDR report key: 7408789
·
Received April 9, 2018
Report
- Report Number
- 3004582654-2018-00014
- Event Type
- Injury
- Date Received
- April 9, 2018
- Date of Event
- March 9, 2018
- Report Date
- April 9, 2018
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- PMA / PMN Number
- P160035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
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). THROMBUS DETECTED IN PUMP, BUT SITE ELECTED NOT TO CHANGE PUMP UNTIL PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2018 AND IS RECOVERING WELL. ADVERSE EVENT TERM: EMBOLISM.
Description of Event or Problem · 0
THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT A PATIENT SUPPORTED BY AN EXCOR BLOOD PUMP IN THE BVAD CONFIGURATION DEVELOPED ACUTE ONSET OF LEFT SIDED HEMIPARESIS, EXPRESSIVE APHASIA, LEFT EYE DEVIATION, LEFT SIDED FACIAL DROOP, AND HEADACHE ON THE MORNING OF (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250408 | BERLIN HEART EXCOR PEDIATRIC VAD | VENTRICULAR ASSIST DEVICE | DSQ | BERLIN HEART GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Life Threatening |