BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 9708505 · Received February 13, 2020

    Report

    Report Number
    8010762-2020-00062
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMMUNICATION FIELD FROM THE TECHNICIAN ON 2020-02-07. THE TECHNICIAN WAS ON SITE TO INVESTIGATE THE DEVICE IN QUESTION. THE BATTERY WAS FULLY DISCHARGED AND CHARGED BY CONNECTING TO AC. AFTER A FEW HOURS, THE BATTERY CHARGING LIGHT WAS OFF SHOWING FULL CHARGE OF THE MACHINE. IN THE SERVICE TERMINAL, THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 256. THE MACHINE WAS THEN KEPT CONNECTING TO AC. AFTER 3 HOURS, THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 248. THE MACHINE WAS LEFT CONNECTING TO AC FOR OVERNIGHT. IN THE NEXT DAY, THE MACHINE WAS SHOWN FULLY CHARGED WITH BATTERY CHARGING LIGHT OFF. THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 236. THE MACHINE WAS THEN UNPLUGGED WITHOUT RUNNING ANY RPM/LPM. THE BATTERY VOLTAGE INITIALLY SHOWED 23.6 AND THEN DROPPED RAPID TO LOW BATTERY AND THEN SHUT DOWN IN 20S. WHEN IT WAS CONNECTED TO AC AGAIN, THE MACHINE WAS ABLE TO START UP AND CHARGE AGAIN. A NEW BATTERY (701017188) WAS REPLACED TO THE MACHINE AND CHARGED WITH THE SAME STEPS AS ABOVE. AFTER OVERNIGHT CHARGING, THE MACHINE WAS FULLY CHARGED WITH BATTERY CHARGING LIGHT OFF. WHEN IT WAS UNPLUGGED, BATTERY VOLTAGE WAS 27 V AND DID NOT DROP RAPIDLY. THE MACHINE WAS THE PUT ON RUNNING 3000 RPM ON BATTERY MODE USING THE SERVICE SET. IT COULD RUN MORE THAN 90 MINS AND EVEN 120 MINS. WE THEN CONCLUDED THAT IT WAS THE BATTERY DEFECTIVE CAUSING THE INCIDENT. THE LAST REPLACEMENT DATE OF THE BATTERY IS 21 MAY 2018, MEANING THAT IT HAS NOT REACHED ITS 2-YEAR REPLACEMENT YET. WE HAVE ALSO CONFIRMED FROM USER THAT THE MACHINE WAS KEPT CONNECTED TO AC NO MATTER IT IS IN USE OR NOT IN USE. THE MACHINE WITH BATTERY REPLACED WAS RETURNED TO USER FOR CLINICAL USE. THUS THE REPORTED FAILURE "BATTERY NOT HOLDING CHARGE" COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS THE LIFE TIME OF THE BATTERY WAS DUE, BASED ON THE INFORMATION THAT THE LAST REPLACEMENT WAS IN MAY 2018. ACCORDING TO THE IFU ROTAFLOW SYSTEM COMPONENTS 3.3.4 BATTERY OPERATION 3.3.4 BATTERY OPERATION: "CHECK BATTERY CAPACITY EVERY 6 MONTHS, AT THE LATEST. THE BATTERY MUST BE REPLACED BY THE AUTHORIZED TECHNICAL SERVICE EVERY 2 YEARS, AT THE LATEST. THE BATTERY MUST BE REPLACED SOONER IF IT CANNOT BE FULLY CHARGED WITHIN 8.5 HOURS OR IF THE SYSTEM CANNOT BE OPERATED WITH THE FULLY CHARGED BATTERY." AND NOTE "THE ACTUAL RUN TIME DURING BATTERY OPERATION DEPENDS ON THE AGE AND CONDITION OF THE BATTERIES, CURRENT CONSUMPTION OF THE ROTAFLOW CONSOLE AND OTHER FACTORS. THE RUN TIME SHOWN IS ONLY A REFERENCE VALUE. THE ACTUAL RUN TIME CAN BE SHORTER OR LONGER." AND AS IT WAS STATED THE LAST REPLACEMENT WAS IN MAY 2018 THE BATTERY WAS DUE THREE MONTHS BEFORE THE NEXT REGULAR 2 YEAR REPLACEMENT. THE REPORTED FAILURE "BATTERY NOT HOLDING CHARGE" OCCURRED DURING TREATMENT AND COULD BE CONFIRMED. THE OCCURRENCE RATE REGARDING THE ABOVE COMPLAINT IS BELOW THE ACCEPTANCE RATE. THUS, NO REMEDIAL ACTION REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A CUSTOMER FROM (B)(6) THAT A FULLY CHARGED ROTAFLOW SHUT DOWN WHEN IT WAS UNPLUGGED FROM AC BY THE USER. THE MACHINE WAS KEPT CONNECTING TO AC AND SHOWN FULLY CHARGED BEFORE DISCONNECTING FROM AC. THE USER SWITCHED TO ANOTHER ROTAFLOW AFTER THE INCIDENT. THE MACHINE WAS COLLECTED BACK TO WORKSHOP FOR INVESTIGATION. THE BATTERY WAS FULLY DISCHARGED AND CHARGED BY CONNECTING TO AC. AFTER A FEW HOURS, THE BATTERY CHARGING LIGHT WAS OFF SHOWING FULL CHARGE OF THE MACHINE. IN THE SERVICE TERMINAL, THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 256. THE MACHINE WAS THEN KEPT CONNECTING TO AC. AFTER 3 HOURS, THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 248. THE MACHINE WAS LEFT CONNECTING TO AC FOR OVERNIGHT. IN THE NEXT DAY, THE MACHINE WAS SHOWN FULLY CHARGED WITH BATTERY CHARGING LIGHT OFF. THE ST STATUS IN THE PSD ROW SHOWED 70 AND U-BAT (BATTERY VOLTAGE) WAS 236. THE MACHINE WAS THEN UNPLUGGED WITHOUT RUNNING ANY RPM/LPM. THE BATTERY VOLTAGE INITIALLY SHOWED 23.6 AND THEN DROPPED RAPID TO LOW BATTERY AND THEN SHUT DOWN IN 20S. WHEN IT WAS CONNECTED TO AC AGAIN, THE MACHINE WAS ABLE TO START UP AND CHARGE AGAIN. A NEW BATTERY WAS REPLACED TO THE MACHINE AND CHARGED WITH THE SAME STEPS AS ABOVE. AFTER OVERNIGHT CHARGING, THE MACHINE WAS FULLY CHARGED WITH BATTERY CHARGING LIGHT OFF. WHEN IT WAS UNPLUGGED, BATTERY VOLTAGE WAS 27 V AND DID NOT DROP RAPIDLY. THE MACHINE WAS THE PUT ON RUNNING 3000 RPM ON BATTERY MODE USING THE SERVICE SET. IT COULD RUN MORE THAN 90 MINS AND EVEN 120 MINS. WE THEN CONCLUDED THAT IT WAS THE BATTERY DEFECTIVE CAUSING THE INCIDENT. THE LAST REPLACEMENT DATE OF THE BATTERY IS 21 MAY 2018, MEANING THAT IT HAS NOT REACHED ITS 2-YEAR REPLACEMENT YET. WE HAVE ALSO CONFIRMED FROM USER THAT THE MACHINE WAS KEPT CONNECTED TO AC NO MATTER IT IS IN USE OR NOT IN USE. THE MACHINE WITH BATTERY REPLACED WAS RETURNED TO USER FOR CLINICAL USE. NO HARM TO THE PATIENT WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170885 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH 701043291 - ROTAFLOW ENGLISH/UK UK-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1