BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR PEDIATRIC

    MDR report key: 3124823 · Received May 17, 2013

    Report

    Report Number
    3124823
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PT IS ON BERLIN HEART. THE PT WAS NOTED TO HAVE POOR EJECTION (<50% EVERY BEAT.) NO CHANGES NOTED IN HEMODYNAMIC STATUS. FLUID LEVELS AND PRESSURES WERE NORMAL AND UNCHANGED. NO HARM WAS CAUSED. DRIVE PRESSURE AND % SYSTOLE WERE INCREASED GRADUALLY FROM 190-250 AND 36-50%. THE DRIVER WAS REPLACED WITH A BACKUP DRIVER TO CHECK INTEGRITY OF COMPRESSOR, BUT NO IMPROVEMENT TO EJECTION. BEGAN HAND PUMPING FOR APPROX 5 MINUTES WHEN EJECTION BECAME 0% EVERY BEAT, NO EFFECT. PUMP REPLACEMENT ORDERED BY CT SURGEON. PUMP WAS EXCHANGED AT ICU BEDSIDE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FUNCTIONING BERLIN PUMP LVAD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220007 EXCOR PEDIATRIC VENTRICULAR (ASSISST) BYPASS DSQ BERLIN HEART GMBH H100004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR EXCOR STATIONARY DRIVING UNIT IKUS