BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 8042096 · Received November 6, 2018

    Report

    Report Number
    3004582654-2018-00053
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 6, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). G8: ADVERSE EVENT TERM: ISCHEMIC CVA.

    Description of Event or Problem · 0

    THE DISTRIBUTER CONTACTED BERLIN HEART (B)(4) ON (B)(6) 2018 TO REPORT A PATIENT SUPPORTED IN THE LVAD CONFIGURATION OF THE EXCOR BLOOD PUMP HAD ISCHEMIC CVA. PATIENT WAS SEDATED AND INTUBATED, TAKING ANTI CONVULSIVE DRUGS. THE ANTIXA WAS 1.2. THE PATIENT IS IN ICU, VENTILATED, SEDATED AND WITHOUT ANY RESPONSE YET. THE SITE CHANGED THE BLOOD PUMP PRIOR TO THE EVENT DUE TO A MOBILE FIBRIN FROM THE ATRIAL CANNULAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883524 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Life Threatening