BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 3944598 · Received June 19, 2014

    Report

    Report Number
    3004582654-2014-00026
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP WAS IMPLANTED ON (B)(6) 2014. PT REMAINS ON DEVICE SUPPORT AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    PT NOTED TO HAVE CLOT IN THE LVAD. PUMP CHANGE OCCURRED ON (B)(6) 2014 BY THE SURGEON. PT HAD A HEAD CT AT 5AM AFTER THE PUMP CHANGE AND WAS NOTED TO HAVE A RIGHT MCA AND CEREBELLUM STROKE. ALSO NOTED BY CT TO HAVE A RENAL ARTERY OCCLUSION AS WELL AS A SPLENIC INFARCT. SITE REPORTED THAT THE CANNULAS WERE CLAMPED DURING THE PUMP EXCHANGE NOT ALLOWING CLOT TO MOBILIZE. SITE ALSO REPORTED POOR CANNULA POSITION WITH POOR FILLING AND EJECTING. THE SITE WAS TREATING THE PT FOR AN ONGOING INFECTION DESPITE NEGATIVE CULTURES. THE PT WAS EMPIRICALLY TREATED WITH ANTIMICROBIAL AND ANTIFUNGAL AGENTS. PT WAS SEDATED AND UNABLE TO ASSESS, WILL WEAN DRUGS. PT IS ONLY (B)(6) BUT DOES OPEN EYES AND LOOK AROUND. PT IS REPORTED TO BE IMPROVING AS OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360373 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSISTED DEVICE DSQ BERLIN HEART GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Life Threatening| R