BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR

    MDR report key: 3173757 · Received June 17, 2013

    Report

    Report Number
    3173757
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BERLIN HEART
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN STABLE ON BIVALVE THIS MORNING; HOWEVER, WE NOTICED THAT SOME MEMBRANE-LIKE FIBRIN TISSUE ALONG WITH LVAD AND RVAD INFLOW CANNULAE. SO WE HAVE DECIDED TO CHANGE OUT BOTH PUMPS WITH THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273190 BERLIN HEART EXCOR BIVAD DSQ BERLIN HEART

    Patients

    Seq Age Sex Outcome Treatment
    1