BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART IKUS STATIONARY DRIVING UNIT

    MDR report key: 22208645 · Received June 15, 2025

    Report

    Report Number
    3004582654-2025-00030
    Event Type
    Malfunction
    Date Received
    June 15, 2025
    Date of Event
    May 17, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040225
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BERLIN HEART RECEIVED THE AFFECTED EXCOR IKUS DRIVER ON 2025-05-22 FOR INVESTIGATION. UPON RECEIPT, THE UNIT WAS INSPECTED BOTH INTERNALLY AND EXTERNALLY. THE INITIAL STARTUP TEST WAS CONDUCTED, AND THE IKUS DRIVER RAN FOR OVER 48 HOURS WITHOUT ANY ISSUES. A COMPLAINT INVESTIGATION WAS CONDUCTED IN COLLABORATION WITH THE SUSTAINING ENGINEERING DEPARTMENT AT THE MANUFACTURER, BERLIN HEART GMBH. AS THE DRIVER NEEDS TO BE INSPECTED BY THE SOFTWARE TEAM, THE DRIVER WAS SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION ON 2025-06-11. UPON REVIEWING THE LOG DATA, IT WAS CONFIRMED THAT THE REPORTED PUMP STOPPED OPERATING ON 2025-05-18 AT 08:24:55. AFTER FURTHER ANALYSIS OF THE LOG DATA, IT WAS OBSERVED THAT THE IKUS DRIVER SUDDENLY TRIGGERED AN ALARM DURING OPERATION WHEN THE USER TRIED TO LOG IN TO THE SYSTEM, SHOWING "BACKUP COMPUTER FAULTY". THE DRIVER SOFTWARE THEN BEGAN GOING THROUGH THE STARTUP PROCESS SIMILAR TO THE INITIAL DRIVER STARTUP WHEN TURNING ON THE DEVICE. THE INITIAL STARTUP TEST BEGAN, ABORTED AND STARTED AGAIN, THIS SEQUENCE OCCURRING 6 TIMES ON 2025-05-18. ABOUT 1 MIN 24 SECONDS AFTER THE INITIAL "BACKUP COMPUTER FAULTY" ERROR, THE IKUS DRIVER LOGGED THE PUMP PARAMETERS 3 TIMES JUST BEFORE THE DRIVER WAS TURNED OFF ON 2025-05-18 AT AROUND 08:27:29. ADDITIONAL ANALYSIS OF THE LOG DATA WITH THE SUPPORT OF A SOFTWARE ENGINEERING TEAM AT THE EXTERNAL SERVICE SUPPLIER, NO EVIDENCE INDICATING A SOFTWARE FAILURE WAS FOUND. THEN, AFTER THE FINAL REVIEW, IT WAS SUSPECTED THAT THE DEFECTIVE "FRAM" (WORKING MEMORY OF THE RUNNING PROCESSING BOARD) LED TO THE CONTROL COMPUTER SWITCHING TO START TEST MODE AS A RESULT FAULT AND REPEATEDLY ABORTING AND RESTARTING IT. THE FRAM ON THE MP2 MAIN PROCESSING BOARD WAS OBSERVED TO BE THE CAUSE OF THE REPORTED FAILURE. AS A RESULT, THE MP2 BOARD, MP1 BOARD AND THE V24 BOARD WERE REPLACED. AFTER REPLACING, THE DRIVER WAS SUBJECTED TO A 48-HOUR CONTINUOUS OPERATION AND PASSED ALL THE TESTS SUCCESSFULLY WITHOUT ANY ERRORS.

    Additional Manufacturer Narrative · 0

    WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR STATIONARY DRIVING UNIT, S/N (B)(6). THERE WERE NO ANOMALIES IN PRODUCTION AND DOCUMENTATION IS ACCORDING TO THE MANUFACTURER SPECIFICATIONS. THE MOST RECENT MAINTENANCE ON THIS DRIVER WAS PERFORMED ACCORDING TO THE SPECIFICATION BY BERLIN HEART SERVICE ENGINEERS ON 2024-08-02. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    ON 2025-05-17 THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS TO REPORT THAT AN EXCOR IKUS DRIVING UNIT CHANGE OCCURRED. ACCORDING TO THE SITE REPORT, THE IKUS DRIVING UNIT WAS IN USE ON A PATIENT SUPPORTED WITH A 10 ML EXCOR BLOOD PUMP, WHEN THE DRIVER BEGAN AUDIBLY ALARMING CONTINUOUSLY AND DISPLAYED A LOGIN ERROR. THE SITE REPORTED THAT THE BLOOD PUMP MEMBRANE STOPPED MOVING DURING THE EVENT. THE SITE ALSO REPORTED THAT THEY HAND PUMPED THE PATIENT WHILE THE AFFECTED IKUS DRIVING UNIT WAS SWITCHED TO THE BACKUP UNIT. ONCE THE BACKUP DRIVING UNIT WAS CONNECTED, THE PUMP MEMBRANE RESUMED MOVEMENT AS INTENDED. THE PATIENT WAS STABLE THROUGHOUT. BHI CA WAS NOTIFIED AFTER THE EVENT, AND THE AFFECTED IKUS DRIVER WAS COLLECTED AS A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899308 BERLIN HEART IKUS STATIONARY DRIVING UNIT VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH D03I-111X00 04260090040225

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Female