BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 8664243 · Received June 3, 2019

    Report

    Report Number
    3004582654-2019-00051
    Event Type
    Death
    Date Received
    June 3, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    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). PATIENT WAS ON EXCOR SYSTEM FROM (B)(6) 2019 TO (B)(6) 2019 (12 DAYS). ADVERSE EVENT TERM: ISCHEMIC CVA.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. ON (B)(6) 2019 TO REPORT A PATIENT SUPPORTED ON THE EXCOR BLOOD PUMP HAD A ISCHEMIC CVA AND DIED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT WAS FOUND TO HAVE LEFT SIDED WEAKNESS AND SMALL FIBRIN STRANDS WERE NOTED IN THE PUMP SUPPORT. NO INTERVENTION COULD BE DONE DUE TO PATIENT SIZE. OVERNIGHT, PATIENT DEVELOPED A FEVER AND DECOMPENSATED REQUIRING REINTUBATION. ON (B)(6) 2019, PATIENT BECAME LESS RESPONSIVE AND ON (B)(6) 2019, THE PARENT'S CHOSE TO WITHDRAW. THE PATIENT HAD A BERLIN HEART CANNULA IMPLANTED ON (B)(6) 2019 WITH PEDIMAG PUMP. PATIENT WAS THEN CONVERTED TO THE BERLIN HEART PUMP ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455397 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death| L