BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 20684687 · Received November 14, 2024

    Report

    Report Number
    3004582654-2024-00057
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    November 4, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMPS PU VALVES; 15 ML IN/OUT; Ø 9 MM; SN (B)(6) WAS IN USE ON THE PATIENT SINCE 2024-09-30 TO DATE. THE EVENT OCCURRED ON 2024-11-04, (35 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, SN (B)(6) AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT ON A WEEKLY UPDATE THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM HAD ELEVATED LDH LEVELS. THE PATIENT'S LDH VALUE INCREASED FROM 1160 U/L TO 3124 U/L. THE SITE REPORTED HEPATIC DYSFUNCTION. THE AST LEVEL WAS ELEVATED FROM 40-60 U/L TO 192 U/L AND ALT LEVEL WAS ELEVATED FROM 5-25 U/L TO 55 U/L. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM; SN (B)(6) PERFORMED AS INTENDED WITH COMPLETE FILL AND EJECTION AND FUNCTIONED AS INTENDED FOR THE CLINICAL CONDITION. THERE WERE NO ABNORMAL SOUNDS FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217206 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Other