BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 23394517 · Received October 27, 2025

    Report

    Report Number
    3004582654-2025-00058
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 27, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040171
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR CANNULA EXTENSION SET (LOT 00156114) WAS IN USE ON THE PATIENT FROM (B)(6) 2025 TO THE CANNULA WAS REPLACED ON (B)(6) 2025. THE EVENT OCCURRED ON 2025-10-01, WHICH IS (13 DAYS) AFTER THE EXTENSION SET WAS PLACED ON THE PATIENT. THE CLINIC PROVIDED BERLIN HEART WITH THREE PHOTOS OF THE CANNULA EXTENSION SET IN QUESTION AT THE TIME OF AND AFTER THE EVENT. THE OBSERVATION DESCRIBED CAN BE CONFIRMED BASED ON THE IMAGES FROM THE CLINIC. THE AFFECTED CANNULA EXTENSION SET WAS NOT RETURNED TO BERLIN HEART FOR INVESTIGATION AND WAS DISCARDED BY THE CLINIC. 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. 00156114. THIS PRODUCT WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. ACCORDING TO THE PRODUCTION RECORD, A TOTAL OF 3 EXTENSION SETS WITH THIS LOT NO. WERE PRODUCED. ALL EXTENSION SETS WERE IMPLANTED IN THE PATIENTS IN THE USA. THERE ARE NO MORE COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER EXCEPT THE CURRENT COMPLAINT.

    Description of Event or Problem · 0

    THE CLINIC CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-10-01 TO REPORT A CONCERN FOR A INTERNAL "SCRATCH OR DEFECT" IN THE EXCOR CANNULA EXTENSION SET ON THE RVAD INFLOW SIDE ON A PATIENT WITH EXCOR BI-VAD CONFIGURATION. ACCORDING TO THE CLINIC, THEY WERE UNSURE IF IT WAS A DEFECT OR A SHADOW BUT WERE CONCERNED FOR THE POSSIBILITY OF A DEFECT DUE TO THE ACTIVITY OF THE CHILD. BHI CA REVIEWED THE IMAGE AND RECOMMENDED A PUMP CHANGE ALONG WITH THE CHANGE OF THE SEGMENT OF THE EXTENSION SET. BHI CA ALSO RECOMMENDED THAT THE SEGMENT OF THE EXTENSION SET IN QUESTION BE RETURNED FOR FURTHER EVALUATION. THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT. ON 2025-10-02, THE CLINIC NOTIFIED THAT AN EXTENSION SET CHANGE HAD OCCURRED. ACCORDING TO THE CLINIC, THE SEGMENT OF THE EXTENSION IN QUESTION WAS DISPOSED OF. THE PATIENT TOLERATED THE EXTENSION SET CHANGE WITH NO UNTOWARD EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2795212 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH A09-009 00156114 04260090040171

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male