BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR

    MDR report key: 3163430 · Received June 11, 2013

    Report

    Report Number
    3163430
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    March 23, 2013
    Report Date
    June 3, 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

    RVAD BEGAN ALARMING. DECREASED FILLING AND DECREASED RVAD EMPTYING. NO CLOT VISUALIZED IN PUMP. PATIENT WAS GIVEN A NS BOLUS AND SBP ON RVAD WAS INCREASED FROM 150 TO 180 WITHOUT IMPROVEMENT. ECHO SHOWED DECREASED RVAD OUTFLOW. RVAD EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264232 BERLIN HEART EXCOR BIVAD DSQ BERLIN HEART

    Patients

    Seq Age Sex Outcome Treatment
    1