BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 22610323 · Received July 25, 2025

    Report

    Report Number
    3004582654-2025-00042
    Event Type
    Death
    Date Received
    July 25, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LVAD EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 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 (B)(6) 2025, WHICH IS (13 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 ITALIAN DISTRIBUTOR ON 2025-07-08 THAT A PATIENT WITH EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; SUFFERED CEREBRAL HEMORRHAGE AND WAS DECEASED ON (B)(6) 2025. THE PATIENT'S DEATH WAS NOT CAUSED BY A THROMBUS IN THE EXCOR PUMP. IT WAS DUE TO A SERIES OF COMPLICATIONS / EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287171 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male Death