BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 22569673 · Received July 22, 2025

    Report

    Report Number
    3004582654-2025-00041
    Event Type
    Death
    Date Received
    July 22, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040010
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LVAD EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2025 UNTIL IT WAS REMOVED FROM THE PATIENT ON (B)(6) 2025. THE EVENT OCCURRED ON 2025-05-08, WHICH IS (63 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ON 2025-07-03 THAT A PATIENT WAS PRESENTED WITH A HEADACHE, AND A CT SCAN WAS PERFORMED. A SMALL HEMORRHAGIC STROKE WAS IDENTIFIED ON (B)(6) 2025. ANTICOAGULATION WAS STOPPED BUT OVER THE NEXT DAYS THE BLEEDING INCREASED, AND THE PATIENT WAS DECLARED BRAIN DEAD AND DIED ON (B)(6) 2025 DUE TO MASSIVE CEREBRAL HEMORRHAGE. THE PATIENT WAS BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM. NO DEPOSITS IN THE EXCOR BLOOD PUMP WERE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295063 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P50P-001 04260090040010

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Death