BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 23413903 · Received October 29, 2025

    Report

    Report Number
    3004582654-2025-00059
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 5, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040171
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR CANNULA EXTENSION SET (LOT 00156115) WAS IN USE ON THE PATIENT FROM 2025-10-02 TO THE CANNULA WAS REPLACED ON (B)(6) 2025. THE EVENT OCCURRED ON (B)(6) 2025, WHICH IS (3 DAYS) AFTER THE EXTENSION SET WAS PLACED ON THE PATIENT. THE AFFECTED CANNULA EXTENSION SET WAS NOT RETURNED TO BERLIN HEART FOR INVESTIGATION, AS THE EXTENSION SET IN QUESTION WAS ALREADY DISCARDED AFTER REPLACEMENT. THEREFORE, NEITHER THE FAILURE NOR THE CAUSE OF THE FAILURE IN QUESTION COULD BE DETERMINED. WE HAVE REVIEWED THE DEVICE HISTORY RECORD (DHR) OF THE EXTENSION SET LOT NO. 00156115. THIS PRODUCT WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. ACCORDING TO THE PRODUCTION RECORD, A TOTAL OF 6 EXTENSION SETS WITH THIS LOT NO. WERE PRODUCED. ALL EXTENSION SETS WERE DISTRIBUTED IN THE USA. THERE ARE NO MORE COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER EXCEPT THE CURRENT COMPLAINT.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-10-05 TO REPORT A CANNULA BREACH THAT HAD OCCURRED ON THE PATIENT BEING SUPPORTED WITH EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE IN BIVAD CONFIGURATION. ACCORDING TO THE SITE, THE PATIENT WAS SITTING UP IN BED, COUGHED, AND BLOOD STARTED COMING OUT OF THE RVAD OUTFLOW EXCOR CANNULA EXTENSION SET, A09-009 JUST ABOVE THE TITANIUM CONNECTOR OF THE BLOOD PUMP. THE NURSE PINCHED THE CANNULA, THE OUTFLOW CANNULA WAS CLAMPED, AND THE EXTENSION SET WAS CHANGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT AND CONTINUES AT THEIR NEUROLOGICAL BASELINE. AT THE TIME OF THE REPORT, THE 9-9 EXTENSION IN QUESTION HAD ALREADY BEEN DISPOSED OF AND NO PICTURES WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215195 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH A09-009 00156115 04260090040171

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male