BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 10683970 · Received October 15, 2020

    Report

    Report Number
    3008454189-2020-00005
    Event Type
    Death
    Date Received
    October 15, 2020
    Date of Event
    September 19, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A REPEAT CT SCAN ON (B)(6) 2020 SHOWED A SUBARACHNOID HEMORRHAGE AND AFTER NO SIGN OF RECOVERY THE CLINICIANS DISCUSSED THE POOR PROGNOSIS WITH THE FAMILY AND THE DECISION WAS MADE TO WITHDRAW SUPPORT AND ON (B)(6) 2020 THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    BERLIN HEART WAS INFORMED BY THE SITE ON (B)(6) 2020 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM IN THE BIVAD CONFIGURATION HAD EXPERIENCED A SIGNIFICANT NEUROLOGICAL EVENT AND THAT THE SITE WAS GOING TO WITHDRAW SUPPORT. ON (B)(6) 2020 THE SITE NOTICED THAT THE PATIENT LOST MOVEMENT IN THEIR RIGHT ARM. A CT SCAN PERFORMED ON THE SAME DAY SHOWED AN LMCA ISCHEMIC EVENT. THE SITE REPORTED THAT THE EXCOR BLOOD PUMPS WERE COMPLETELY FILLING AND EJECTING AND THAT A SMALL AMOUNT OF FIBRIN WAS NOTED IN THE PUMP WHEN THEY NOTICED THAT THE PATIENT LOST MOVEMENT IN HIS RIGHT ARM. ON (B)(6) 2020, A REPEAT CT SCAN SHOWED A SUBARACHNOID HEMORRHAGE AND SUBSEQUENTLY, THERE WERE NO SIGNS OF NEUROLOGICAL RECOVERY. THE CLINICIANS DISCUSSED THE POOR PROGNOSIS WITH THE PATIENTS FAMILY AND THE DECISION WAS MADE TO WITHDRAW SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151218 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death| L