BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 21647462 · Received March 19, 2025

    Report

    Report Number
    3004582654-2025-00015
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 10, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; (B)(6) HAS BEEN IN USE ON THE PATIENT SINCE (B)(6) 2025 TO DATE. THE EVENT OCCURRED ON (B)(6)2025, WHICH IS (11 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

    THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS ON (B)(6) 2025 TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM EXPERIENCED HEMOLYSIS. THE PATIENT'S LDH LEVELS INCREASED FROM 684 U/L TO1800 U/L, AND PFHGB TO 7.4 MG/DL ON (B)(6) 2025. THE PRE PFHGB WAS 10.6 MG/DL. THE PATIENT CONTINUES TO REMAIN ON THE SAME PUMP. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILL AND EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562395 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other