BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART IKUS STATIONARY DRIVING UNIT

    MDR report key: 5539026 · Received March 31, 2016

    Report

    Report Number
    3004582654-2016-00013
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    March 6, 2016
    Report Date
    March 6, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040225
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). UPON RETURN THE DRIVING UNIT WAS THOROUGHLY INSPECTED EXTERNALLY AND INTERNALLY. THE IKUS WAS STARTED, PASSED SELF-TEST, AND FUNCTIONED AS DESIGNED. ON FURTHER EVALUATION OF THE IKUS, BATTERY DISCHARGE TEST WAS PERFORMED AND REVEALED THAT THE RIGHT BATTERY VOLTAGE DROPPED RAPIDLY BELOW THE REQUIRED VOLTAGE VALUE OF GREATER THAN 10.8 VDC IN 60 MINUTES. THE TESTER ABORTED THE DISCHARGE TEST. THE IKUS THEN MANUALLY SWITCHED TO BATTERY MODE, THE RIGHT BATTERY RAPIDLY DROPPED VOLTAGE AND IKUS ALARMED "BATTERIES DISCHARGED - USE POWER SUPPLY" MULTIPLE TIMES, AND THE LOW VOLTAGE "CHIRP" ALARM COULD BE HEARD. THE IKUS STOPPED FUNCTIONING AND ALL THREE PNEUMATICS SYSTEMS SHUT DOWN. THE IKUS WAS THEN MANUALLY SWITCHED TO MAINS POWER, PAUSED, AND RESTARTED. THE IKUS THEN BEGAN FUNCTIONING AS DESIGNED. AFTER CONSULTATION WITH R & D ENGINEER FROM BERLIN HEART (B)(4), THE MANUFACTURER OF IKUS UNIT, IT WAS DETERMINED THAT THE RIGHT BATTERY HAD FAILED. REVIEW OF THE LOG FILES SHOWED THAT THE UNIT HAD BEEN USED ON BATTERY MODE WITHOUT ALLOWING ENOUGH TIME FOR BATTERIES TO RECHARGE. THIS LIKELY CAUSED THE RIGHT BATTERY TO FAIL. "BATTERIES DISCHARGED: USE POWER SUPPLY" MESSAGE APPEARED AFTER SEVERAL USES OF BATTERY MODE WITHOUT PROPER RECHARGING. THE LOG ALSO SHOWED THAT THE IKUS ALARMED "BATTERIES DISCHARGED - USE POWER SUPPLY" MORE THAN 20 TIMES BEFORE THE IKUS STOPPED FUNCTIONING AT SITE. CUSTOMER USED POWER CORDS OTHER THAN WHAT BERLIN HEART PROVIDED, WHICH WERE NOTABLY LONGER. THIS PRACTICE NOT RECOMMENDED BY THE MANUFACTURER. THE IKUS FAILURE CAUSED BY THE USER ERROR, USING THE IKUS IN BATTERY MODE WITHOUT ALLOWING ENOUGH TIME FOR BATTERIES TO RECHARGE, AS RECOMMENDED IN THE IFU 1000721X09 REV 8, PAGE 7. AS OF 3.24.2016, THE PATIENT IS STABLE AND HAD NOT ISSUES FROM THIS INCIDENT.

    Description of Event or Problem · 0

    BERLIN HEART INC. CLINICAL AFFAIRS (CA) RECEIVED A CALL ON 3/6/2016 THAT THE IKUS MENTIONED ABOVE PRODUCED AN ERROR MESSAGE "BATTERIES DEPLETED, PLEASE CONNECT TO MAINS POWER SUPPLY" WHILE ON POWER SUPPLY FOR 10 OR 20 MINUTES. AT THE TIME OF THIS INCIDENT, ALL SEVEN BATTERY LEDS WERE ON AND THE IKUS WAS FUNCTIONING WELL WITH NO ISSUES. BERLIN HEART INC. SERVICE ENGINEER REVIEWED THE LOG FILES SENT BY THE SITE AND REPORTED THAT THE LOG FILES HAD INDICATED THAT THE IKUS WAS BEING USED ON BATTERY MODE MULTIPLE TIMES, FOR APPROXIMATELY 5-15 MINUTES AT A TIME WITHOUT ALLOWING FULLY RECHARGE THE BATTERIES. THIS WAS COMMUNICATED TO THE SITE. AT THIS TIME, THE SITE REPORTED THAT IT WAS USING A LONG POWER CORD AND AN EXTENSION CORD TO LIMIT BATTERY USAGE. ON (B)(6) 2016, THE SITE CALLED CA TO REPORT THAT THE IKUS HAD STOPPED PUMPING WHILE ON AN EXTENSION CORD AND THAT THE NURSE USED THE HAND-PUMP TO SUPPORT THE PATIENT UNTIL THE PATIENT COULD BE TRANSITIONED TO THE BACK-UP IKUS. THE NURSE REPORTED HEARING A CHIRPING ALARM FROM THE IKUS BEFORE CONFIRMING THE EXCOR BLOOD PUMP HAD STOPPED EJECTING PRIOR TO HAND PUMPING. THE PATIENT WAS PLACED ON THE BACK UP IKUS AND SUFFERED NO UNTOWARD EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193431 BERLIN HEART IKUS STATIONARY DRIVING UNIT VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH D03I-111 04260090040225

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO