BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART EXCOR VAD

    MDR report key: 5546856 · Received April 1, 2016

    Report

    Report Number
    MW5061459
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 18, 2016
    Report Date
    March 18, 2016
    Manufacturer
    BERLIN HEART
    Product Code
    PCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197587 BERLIN HEART EXCOR VAD BERLIN HEART EXCOR VAD PCK BERLIN HEART P10P 10M 1320554

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO