BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 21057090 · Received January 2, 2025

    Report

    Report Number
    3004582654-2025-00002
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 7, 2024
    Report Date
    January 2, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040010
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP PU VALVES; 50 ML IN/OUT; Ø 12 MM; LVAD SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6)2024 UNTIL THE PUMP WAS EXCHANGED ON (B)(6)2024 (31 DAYS). 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 CLINIC THAT DURING THE NIGHT OF (B)(6)2024 THE PATIENT SUPPORTED WITH AN EXCOR PEDIATRIC SYSTEM IN BI-VAD CONFIGURATION, SHOWED VERY SHORT SPEECH WEAKNESS. A HEAD CT SCAN WAS PERFORMED AND SHOWED HEMORRHAGIC STROKE. THE ANTICOAGULATION HAS BEEN STOPPED UPON THE RECOMMENDATION OF A NEURO CONSULTANT AT CLINIC. MOREOVER, ON (B)(6)2024, THROMBUS WAS SEEN IN THE OUTFLOW VALVE AREA OF THE LVAD, AND A DECISION WAS MADE TO CHANGE THE LVAD PUMP. HOWEVER, THE THROMBUS WAS NO LONGER PRESENT AT THE TIME THE SURGEON ARRIVED. THEREFORE, THE PUMP WAS NOT CHANGED. DURING THE EVENING OF (B)(6)2024., A SMALL FIBRIN/THROMBUS LAYER WAS OBSERVED IN THE LVAD, AND IT WAS DECIDED TO MONITOR THE PUMP. THE PUMP WAS LATER CHANGED ON (B)(6)2024 AFTER HEMORRHAGIC STROKE AND THE PATIENT REMAINED ASYMPTOMATIC UNTIL THE MORNING. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED WITH FULL FILL AND EJECTION. THE PATIENT SHOWED NO SIGNS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387620 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P50P-001 04260090040010

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Other