BERLIN HEART EXCOR PEDIATRIC VAD
Report
- Report Number
- 3004582654-2018-00048
- Event Type
- Injury
- Date Received
- September 27, 2018
- Date of Event
- September 10, 2018
- Report Date
- September 27, 2018
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- PMA / PMN Number
- P160035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- NURSE
Narratives
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). A FOLLOW UP ON THE PATIENT CONFIRMED A VON WILEBRAND DEFICIENCY. G8: ADVERSE EVENT TERM: ISCHEMIC CVA.
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). A CORRECTION TO THE H1, THE TYPE OF REPORTABLE EVENT IS SERIOUS INJURY, NOT MALFUNCTION.
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). CORRECTION TO THE B5. DESCRIBE THE EVENT OR PROBLEM: THE SITE CONTACTED BERLIN HEART INC. ON SEPTEMBER 11, 2018, NOT SEPTEMBER 10, 2018.
ON (B)(6) 2018, THE SITE CONTACTED BERLIN HEART INC. TO REPORT A PATIENT SUPPORTED IN BVAD CONFIGURATION OF THE EXCOR BLOOD PUMP HAD AN ISCHEMIC CVA. PATIENT HAD A PUMP CHANGE ON THE LVAD PUMP IN BVAD CONFIGURATION ON (B)(6) 2018 DUE TO THROMBUS IN THE PUMP. DURING PHYSICAL THERAPY ON (B)(6) 2018, DECREASED MOBILITY WAS NOTED ON THE PATIENTS LEFT SIDE. AN RVAD PUMP CHANGE OCCURRED ON (B)(6) 2018 DUE TO THROMBUS IN THE OUTFLOW VALVE. ANTICOAGULATION WAS FOUND TO BE BELOW TARGET RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 755924 | BERLIN HEART EXCOR PEDIATRIC VAD | VENTRICULAR ASSIST DEVICE | DSQ | BERLIN HEART GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 MO | Other |