BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 11860215 · Received May 20, 2021

    Report

    Report Number
    3004582654-2021-00028
    Event Type
    Death
    Date Received
    May 20, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BERLIN HEART, (B)(4) INFORMED BY THE SITE THAT A PATIENT THAT WAS IMPLANTED IN THE LVAD CONFIGURATION HAD AN ADVERSE EVENT ON (B)(6) 2021. THE SITE REPORTED THAT THE PATIENT SUFFERED FROM A MASSIVE HEMORRHAGIC CVA. THE PATIENT WAS ADMITTED FROM HOME ON (B)(6) 2021 FOR A PLANNED PUMP CHANGE DUE TO USE OF THE PUMP FOR A MAXIMUM OF 1 YEAR. ON THE MORNING OF (B)(6) 2021, THE PATIENT VOMITED AND DEVELOPED CRAMPING. A CT SCAN WAS PERFORMED AND DEMONSTRATED A MASSIVE HEMORRHAGIC CVA IN THE LEFT HEMISPHERE. IT WAS ALSO REPORTED THAT AN INFARCTION OCCURRED AND WAS FOLLOWED BY BLEEDING. THE BLOOD PUMP WAS FULLY FILLING AND EJECTING AT THE TIME OF THE EVENT. THE SITE DID REPORT THAT SMALL WHITE FIBRIN DEPOSITS WERE NOTED IN THE PUMP AT THE TIME OF THE EVENT. THE PATIENT DIED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751816 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death| R