BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 19488501 · Received June 7, 2024

    Report

    Report Number
    3004582654-2024-00026
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 10, 2024
    Report Date
    October 14, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BERLIN HEART GMBH RECEIVED THE EXCOR IKUS DRIVER ON (B)(6) 2024 FOR INVESTIGATION. UPON RECEIVING, THE UNIT WAS INSPECTED BOTH INTERNALLY AND EXTERNALLY. THE DRIVER PASSED THE INITIAL START-UP TEST WITHOUT ANY ERRORS. IN ADDITION, THE UNIT WAS SUBJECTED TO 24 HOURS OF CONTINUOUS OPERATION ON A MOCK LOOP USING THE PNEUMATIC SETTINGS PROVIDED BY THE SITE AND NO ISSUES WERE OBSERVED. THEREFORE, THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. HOWEVER, LOG FILE REVIEW REVEALED THE REPORTED FAILURE ON (B)(6) 2024, WHICH CONFIRMED THE COMPLAINT. BASED ON INVESTIGATION FINDING IT WAS DETERMINED THAT THE DEFECTIVE RELAY BOARD CAUSED THE REPORTED PROBLEM. COMPLETE FAILURE INVESTIGATION REPORT IS ATTACHED.

    Additional Manufacturer Narrative · 0

    WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONERY DRIVING UNIT, S/N (B)(6). LAST MAINTENANCE ON THIS DRIVER WAS PERFORMED BY BERLIN HEART SERVICE ENGINEERS ON 2/2/2024 ACCORDING TO THE SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED THAT THE BERLIN HEART IKUS STATIONARY DRIVING UNIT, TRIGGERED AN ALARM THAT DISPLAYED "SYSTEM 1 DEFECTIVE" WHEN A NURSE UNPLUGGED THE IKUS FROM THE MAIN POWER TO MOVE THE PATIENT AROUND. THEREAFTER, THE DRIVER STOPPED FUNCTIONING. THE PATIENT WAS LATER SUPPORTED BY A MANUAL PUMP UNTIL THE BACKUP UNIT WAS READY. ACCORDING TO THE INFORMATION PROVIDED BY THE SITE, THE PATIENT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264882 EXCOR® VENTRICULAR (ASSISST) BYPASS DSQ BERLIN HEART GMBH D03I-111

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male