BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 17379324 · Received July 24, 2023

    Report

    Report Number
    8010762-2023-00349
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    July 11, 2023
    Report Date
    January 29, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE US. IT WAS REPORTED THAT THE BATTERY OF ROTAFLOW CONSOLE (RFC) DRAINED TO 21 VOLTS IN UNDER A MINUTE WHILE THE DEVICE WAS DISCONNECTED FROM AC POWER DURING PATIENT TREATMENT. THE ROTAFLOW CONSOLE WAS RECONNECTED TO AC POWER, AND AFTERWARDS IT WAS EXCHANGED FOR A BACKUP RFC DEVICE. THE PATIENT WAS WITHOUT SUPPORT FOR 30 SECONDS HOWEVER, WITH NO NEGATIVE CONSEQUENCES FOR THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS SERVICED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE TECHNICIAN WAS UNABLE TO CONFIRM THE REPORTED FAILURE. THE BATTERY COULD BE CHARGED AS INTENDED. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED BY THE TECHNICIAN AS AN USER ERROR. NO PARTS HAS BEEN REPLACED. PERFORMED ALL FUNCTIONAL AND SAFETY TESTS. THE DEVICE IS BACK IN USE. BASED ON THE THE GIVEN INFORMATION THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, THE FAILURE MODE "BATTERY POWER DRAINED TO 21 V UNDER ONE MINUTE" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE. BATTERY POWER FAILURE E.G.: 1. USER FORGOT RECHARGE A REVIEW OF NON-CONFORMITIES WAS PERFORMED ON 2023-07-19, AND DURING THE TIME FROM 2010-09-30 TO 2023-07-19 THERE ARE NO NON-CONFORMITIES IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE ROTAFLOW CONSOLE WITH S/N (B)(6) WAS PRODUCED ON 2010-09-30. IN ORDER TO AVOID REOCCURRENCE OF THE REPORTED FAILURE, THE CUSTOMER WILL BE INFORMED BY THE GETINGE SALES AND SERVICE UNIT (SSU) TO FOLLOW THE CHAPTER IN THE INSTRUCTION FOR USE HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / V15. CHAPTER 3.3.4 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. 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. CHAPTER 5.6.1 BEFORE STARTING THE APPLICATION, CHECK THE POINTS LISTED IN "CHECK BEFORE EVERY USE". BEFORE EACH USE, ENSURE THAT THE BATTERIES ARE FULLY CHARGED. IF THE BATTERY CAPACITY IS LOW AN ACOUSTIC SIGNAL SOUNDS ON THE DEVICE. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS 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 · 0

    THE EVENT OCCURRED IN THE USA DURING PATIENT TRANSPORT. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE (RFC)¿S BATTERY DRAINED IN ONE MINUTE AFTER THE DEVICE WAS DISCONNECTED FROM AC POWER. THE RFC WAS RECONNECTED TO AC POWER, AND AFTERWARDS IT WAS EXCHANGED FOR A BACKUP RFC DEVICE, WITH NO NEGATIVE CONSEQUENCES FOR THE PATIENT. COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    COMPLAINT I: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864806 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH/US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention