BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 24677140 · Received March 24, 2026

    Report

    Report Number
    3004582654-2026-00017
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 18, 2026
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040225
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N 08-2070. THERE WERE NO ANOMALIES IN PRODUCTION AND DOCUMENTATION IS ACCORDING TO THE MANUFACTURER SPECIFICATIONS. LAST MAINTENANCE ON THIS DRIVER WAS PERFORMED BY BERLIN HEART SERVICE ENGINEERS ON 2025-12-18 ACCORDING TO THE SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2026 THE SITE CONTACTED BERLIN HEART INC. (BHI) VIA THE EMERGENCY HOTLINE TO REPORT THAT THE EXCOR IKUS DRIVING UNIT HAD STOPPED PUMPING. THE SITE STATED THAT THE PATIENT HAD RECEIVED "SEVERAL CHECK LEFT PUMP AND DRIVE" ALARMS IN A ROW. WHEN THE BEDSIDE NURSE LOGGED INTO THE IKUS TO MANUALLY CLEAR THE ALARM, THE LAPTOP OF THE IKUS HAD NO PRESSURE SETTINGS DISPLAYED, AND THE BLOOD PUMP MEMBRANE WAS NOT MOVING. ACCORDING TO THE SITE, "THE BOXES FOR THE PRESSURES WERE COMPLETELY BLANKED OUT." THE SITE INFORMED THE BHI CLINICAL AFFAIRS (CA) THAT THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT AND WAS SUPPORTED VIA HAND PUMPING. FOLLOWING ADVICE FROM BHI CA THE BACK-UP IKUS WAS SWITCHED AND THE EXCOR BLOOD PUMP RESUMED EXPECTED FUNCTION, WITH COMPLETE FILLING AND EJECTION. BASED ON THE ADDITIONAL INFORMATION UPDATED BY THE SITE ON 2026-03-03 WHEN THE IKUS WAS LOGGED IN, "THE SETTINGS BOXES WENT BLANK, THE PRESSURE GRAPH DISAPPEARED, AND THE MESSAGE BOX DISPLAYED A DRIVE FAILURE MESSAGE". ADDITIONALLY, THE SITE REPORTED THAT THERE WERE NO "PUMPING SOUNDS" COMING FROM THE IKUS, AND WHEN THE DRIVELINE WAS DISCONNECTED FROM THE IKUS TO HAND PUMP, THERE WERE NO AUDIBLE ALARMS FROM THE IKUS. BEFORE RETURNING THE DRIVER ON (B)(6) 2026, THE VAD COORDINATORS STARTED THE IKUS, IT PASSED SELF-TEST, AND WHILE RUNNING IT ON THE TANK UNITS, THERE WAS A VERY LOUD, DEEP, VIBRATING SOUNDS THAT WAS "NOT THE NORMAL LOUD IKUS OPERATIONAL SOUNDS", AND THE PRESSURE GRAPH LOOKED ABNORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150123 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH D03I-111 04260090040225

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male