BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 23327065 · Received October 17, 2025

    Report

    Report Number
    3004582654-2025-00056
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    March 22, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, SN (B)(6), WAS IN USE FROM (B)(6) 2024 UNTIL THE PUMP WAS REPLACED ON (B)(6) 2025. THE EVENT OCCURRED ON 2025-03-22, WHICH IS 194 DAYS AFTER THE PUMP IN QUESTION WAS PLACED ON THE PATIENT. ON THE SAME DAY AS THE EVENT, THE AFFECTED PUMP WAS REPLACED AND SENT TO BERLIN HEART FOR INVESTIGATION. DURING THE VISUAL INSPECTION OF THE RETURNED BLOOD PUMP, A PILLOW-LIKE STRUCTURE WAS DETECTED. THE BLOOD PUMP WAS TESTED FOR FUNCTIONALITY. THE PUMP PERFORMANCE WAS APPROXIMATELY 40% AND THE BLOOD PUMP DID NOT FILL AND EMPTY COMPLETELY. FOR INTERNAL EVALUATION, THE BLOOD PUMP WAS OPENED AND THE INDIVIDUAL MEMBRANE LAYERS WERE EXAMINED. A LEAK WAS DETECTED IN THE AIR-SIDE AREA OF THE TRIPLE-LAYER MEMBRANE. THE LEAKAGE WAS LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING, AND GRAPHITE AGGLOMERATES WERE OBSERVED BETWEEN THE MEMBRANES. THE BLOOD SIDE AND THE MIDDLE LAYER OF THE MEMBRANE REMAINED INTACT. THE MEMBRANE THICKNESS OF THE DEFECTIVE AIR-SIDE LAYER AND THE ADJACENT LAYER WERE MEASURED. THE MEMBRANE THICKNESS MET THE SPECIFICATIONS AT ALL MEASURING POINTS AND IN THE AREA OF THE LEAK. BASED ON THE EVALUATION, THE CAUSE OF THE FAILURE IS MOST LIKELY ABRASION BETWEEN THE MEMBRANES. THE RESULTING GRAPHITE AGGLOMERATES LED TO INCREASED FRICTION BETWEEN THE MEMBRANE LAYERS AT CERTAIN POINTS, WHICH ULTIMATELY LED TO THE DEFECT IN THE AIR-SIDE LAYER OF THE TRIPLE-LAYER MEMBRANE. THE DEFECT CAUSED A FORMATION OF AIR POCKETS BETWEEN THE MEMBRANES, WHICH RESULTED IN A REDUCED DELIVERY VOLUME (INCOMPLETE FILLING AND EMPTYING) OF THE BLOOD PUMP.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS (CA) WAS INFORMED BY THE ITALIAN DISTRIBUTOR ON 2025-03-23 THAT A PUMP CHANGE WAS PERFORMED DUE TO A SUSPICIOUS MEMBRANE ISSUE ON THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM. THE SITE CHANGED THE PUMP WITHOUT COMPLICATIONS AND REPORTED THAT THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE PATIENT HAD NO NEGATIVE EFFECTS DUE TO THE INCIDENT. THEREFORE, INITIALLY BERLIN HEART HAS DETERMINED THIS EVENT AS NOT REPORTABLE. HOWEVER UPON REVIEWING THE FAILURE INVESTIGATION ON 2025-09-17, THE EVENT WAS DETERMINED AS REPORTABLE DUE TO A CONFIRMED DEFECT IN ONE OF THE LAYERS OF THE TRIPLE LAYER MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2860921 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female