BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    EXCOR®

    MDR report key: 20279020 · Received September 23, 2024

    Report

    Report Number
    3004582654-2024-00043
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 26, 2024
    Report Date
    February 21, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER AND UDI NUMBER IN THE BOX D.4, AND MANUFACTURING DATE IN THE H.4 WERE ENTERED INCORRECTLY IN THE INITIAL REPORT, WHICH HAVE BEEN CORRECTED IN THE FOLLOW-UP-1 REPORT. THE COMPONENT CODE HAS BEEN ADDED IN THE BOX H.6. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N: (B)(6). LAST MAINTENANCE ON THIS DRIVER WAS PERFORMED BY BERLIN HEART SERVICE ENGINEERS ON 2024-06-05 ACCORDING TO THE SPECIFICATION. THE AFFECTED DRIVER WAS NOT RETURNED TO BERLIN HEART FOR INVESTIGATION UNTIL IT WAS DUE FOR REGULAR MAINTENANCE, AS THE PATIENT WAS STILL BEING SUPPORTED BY THE DRIVER. THE DRIVER IN QUESTION CONTINUED TO REMAIN ON THE PATIENT FOR ANOTHER 7 WEEKS AFTER THE EVENT, UNTIL IT WAS DUE FOR MAINTENANCE. HOWEVER, THE LOG FILES OF THE REPORTED EVENT WERE AVAILABLE TO THE MANUFACTURER FOR ANALYSIS. THE REPORTED INCIDENT OCCURRED ON (B)(6) 2024. THE INITIAL FAILURE ANALYSIS WAS THEREFORE PERFORMED SOLELY BASED ON LOG FILES, BUT THEN SUBSEQUENTLY SUPPORTED BY AN INVESTIGATION OF THE PHYSICAL DRIVER ONCE IT WAS AVAILABLE IN THE SERVICE DEPARTMENT OF BERLIN HEART GMBH IN DECEMBER 2024. THE DRIVER WAS USED IN BI-VENTRICULAR ASSIST DEVICE (BI-VAD) MODE STARTING (B)(6) 2024. THE IKUS DRIVER WAS CONNECTED TO THE PATIENT FROM ON (B)(6) 2024, UNTIL IT WAS REMOVED ON (B)(6) 2024. IT IS NOT CLEAR WHETHER THE DRIVER WAS USED ON ANY OTHER PATIENT FROM OCTOBER UNTIL THE DRIVER WAS RETURNED TO THE MANUFACTURER FOR SCHEDULED SERVICE IN DECEMBER. ACCORDING TO THE COMPLAINT REPORT, ON (B)(6) 2024, THE PATIENT INTENTIONALLY DISCONNECTED THE DRIVER LINE FOR A VERY BRIEF PERIOD AND RECONNECTED IT. UPON REVIEWING THE LOG DATA, IT WAS OBSERVED THAT THE LOG FILE FROM ON (B)(6) 2024, WAS CORRUPTED. CONSEQUENTLY, DATA FROM 3:52 PM ON (B)(6) 2024, TO 2:01 AM ON (B)(6) 2024, WAS MISSING. AS THE DATA FOR THIS PERIOD IS UNAVAILABLE, IT CANNOT BE CONFIRMED IF A FAILURE OCCURRED DURING THIS TIME. AFTER THE DRIVER WAS RETURNED TO THE MANUFACTURER, IT WAS CONNECTED TO A MOCK LOOP FOR TESTING. DURING THIS PROCESS, THE DRIVE LINE WAS BRIEFLY DISCONNECTED AND RECONNECTED. THE DRIVER RESPONDED APPROPRIATELY, GENERATING AN ALARM AND SUCCESSFULLY FILLING AND EJECTING THE MOCK LOOP PUMPS WHILE CONNECTED. THE IKUS DRIVER WAS THOROUGHLY CHECKED USING SEVERAL MOCK LOOPS AND PRESSURE TANK UNITS. THE BEHAVIOR OF THE PRESSURE CURVES INCLUDING THE FLOW TESTS WERE VERIFIED, AND THE IKUS DRIVER PASSED ALL THE TESTS WITHOUT ANY ISSUES. IT WAS REPORTED THAT DURING THE EVENT ON AUGUST 26, 2024, THE PATIENT DISCONNECTED THE DRIVER LINE FOR A VERY BRIEF PERIOD AND RECONNECTED IT. THIS EXPLAINS THE ABSENCE OF DEVIATIONS IN THE DRIVER'S FLOW SIGNAL, INDICATING THAT THE DRIVER MAY HAVE NOT BEEN ALARMED DURING THIS BRIEF EVENT. FURTHER ANALYSIS OF THE IKUS DRIVER REVEALED THAT THE LOG FILES WERE TAKING LONGER TO SAVE, AND SOME FILES BECAME CORRUPTED. IT WAS SUSPECTED THAT THE LOG FILE WAS DAMAGED DURING THE SAVING PROCESS ON THE HARD DISK OF THE LAPTOP. SINCE CORRUPTED LOG DATA IS UNUSUAL, THE LAPTOP WAS SUSPECTED TO BE DEFECTIVE AND WAS REPLACED AS A PRECAUTIONARY MEASURE. DURING TESTING AND MAINTENANCE, NO ISSUES WERE OBSERVED WITH THE DRIVER'S PRESSURE OR FLOW SIGNALS, AND THE IKUS DRIVER FUNCTIONED AS INTENDED. BASED ON THIS AND AFTER THOROUGHLY REVIEWING THE REMAINING LOG DATA INCLUDING THE FACT THAT THE DRIVER REMAINED CONNECTED TO THE PATIENT FOR MORE THAN A MONTH AFTER THE REPORTED DISCONNECTION EVENT, IT IS PRESUMED THAT THE DRIVER PERFORMED AS EXPECTED FOR THE ENTIRE PERIOD IT WAS IN USE WITH THE PATIENT. ALTHOUGH THE MALFUNCTION RELATED TO LOGGING COULD NOT BE DUPLICATED DURING THE FAILURE ANALYSIS, IT COULD BE SEEN THAT THE LAPTOP EXPERIENCED PROBLEMS WHEN WRITING TO ITS HARD DISC DRIVE. IT IS UNCLEAR WHEN EXACTLY THE EVENT TOOK PLACE, WHICH IS LIKELY DURING THE PERIOD THAT THE LOG DATA IS MISSING. HOWEVER, THE COMPLAINT TEXT FROM THE CLINIC STATES THAT THE PATIENT WAS NOT HARMED AND THAT HE TERMINATED THE SHORT DISCONNECTION HIMSELF BY IMMEDIATELY RECONNECTING THE PLUG. DURING THE INSPECTION OF THE DRIVER, IT WORKED AND ALARMED AS INTENDED, EITHER WITH LAPTOP SWITCHED ON OR OFF OR WITH A CLOSED DISPLAY. BESIDES THE INTERMITTENT LOGGING ISSUE, NO MALFUNCTION OF THE DRIVER COULD BE IDENTIFIED. BASED ON THE FAILURE ANALYSIS AND THE REPORTED STATEMENT, THE EVENT HAS BEEN CLASSIFIED AS A USER ERROR. THE IFU (1000721X21 REV. 16) INCLUDES A WARNING FOR THE PATIENT, FAMILY AND CAREGIVER TO AVOID PULLING, KINKING OR ENGAGING IN ANY ACTIVITY THAT COULD PUT STRESS ON THE DRIVING TUBES. THE MEASURES IN PLACE TO PROTECT THE PATIENT FUNCTIONED AS INTENDED. TO MITIGATE THE RISK OF FUTURE DATA LOSS, THE LAPTOP HAS BEEN REPLACED AS A PREVENTIVE MEASURE. THE REPORTED COMPLAINT COULD NEITHER BE CONFIRMED NOR REPRODUCED.

    Additional Manufacturer Narrative · 0

    WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N (B)(6). LAST MAINTENANCE ON THIS DRIVER WAS PERFORMED BY BERLIN HEART SERVICE ENGINEERS ON 2024-02-14 ACCORDING TO THE SPECIFICATION. IT IS NOT ABLE TO INVESTIGATE THE EVENT AS THE PATIENT IS STILL BEING SUPPORTED WITH THE IKUS DRIVER IN QUESTION.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE ISRAELI DISTRIBUTOR THAT ON (B)(6) 2024 THE PATIENT BEING SUPPORTED WITH BERLIN HEART IKUS STATIONARY DRIVING UNIT INTENTIONALLY REMOVED ONE OF THE EXCOR DRIVING TUBE FROM THE DRIVER. THE PATIENT INTENTIONALLY REMOVED ONE OF THE DRIVING TUBES, AND MANAGED TO RECONNECT THE DRIVING TUBE BACK. NO HARM HAS OCCURRED TO THE PATIENT. ACCORDING TO THE SITE, THE PATIENT, WHO WAS ORIGINALLY IMPLANTED WITH BVAD, REMAINED STABLE THROUGHOUT THE EVENT, AND BOTH OF THE PUMPS MAINTAINED COMPLETE FILLING AND EJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488701 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH D03I-111

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male