BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 21496535 · Received February 28, 2025

    Report

    Report Number
    3004582654-2025-00013
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    February 16, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 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 TO DATE. THE EVENT OCCURRED ON 2025-02-16, WHICH IS (10 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) HOTLINE TO REPORT THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM EXPERIENCED HEMOLYSIS SECONDARY TO SEPTIC SHOCK OVER THE WEEKEND. PRIOR TO THE EVENT THE PATIENT HAD ELEVATED LDH LEVELS OF 600 U/L, THAT SIGNIFICANTLY INCREASED AFTERWARD. ON (B)(6) 2025 THE LDH LEVEL REPORTED WAS 2000 U/L. THE SITE ALSO STATED THAT THE TEST RESULTS FOR SEPSIS WERE NEGATIVE. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP REDUCED FILLING AT THE TIME OF THE EVENT AS THE PATIENT REQUIRED MORE CARDIAC OUTPUT. THE PUMP MAINTAINED COMPLETE EJECTION. NO DEPOSITS WERE NOTED IN THE EXCOR BLOOD PUMP. THE BLOOD PUMP SN (B)(6) IS STILL ON THE PATIENT AS THE PATIENT CONTINUES TO BE SUPPORTED WITH EXCOR VAD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522692 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P50P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other