BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART EXCOR

    MDR report key: 3001319 · Received March 1, 2013

    Report

    Report Number
    3001319
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BERLIN HEART, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AT MID-MORNING, THE BLOOD PUMP (#1) EMPTYING APPEARED TO BE BRISKED WITH ABOUT 50% EJECTION, BUT APPEARED TO HALT MID-CYCLE. THE BLOOD PUMP WAS CHANGED AT THE BEDSIDE APPROXIMATELY NINE (9) HOURS LATER AFTER NUMEROUS ATTEMPTS OF TROUBLESHOOTING THE DEVICE, WHICH INCLUDED SWITCHING THE IKUS CONSOLE, CHANGING CONSOLE SETTINGS, AND REDRESSING THE VAD SITE. THE BLOOD PUMP (#2) SHOWED GOOD FILLING AND EMPTYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89267 BERLIN HEART EXCOR VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART, INC. 25 ML BERLIN HEART BLOOD PUMP 1220384

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR IKUS DRIVE CONSOLE