BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 16058345 · Received December 28, 2022

    Report

    Report Number
    8010762-2022-00528
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 23, 2022
    Report Date
    March 6, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE BATTERY OF THE ROTAFLOW CONSOLE (RFC) DOESN´T CHARGE. IT WAS NOTICED DURING PATIENT TREATMENT. DURING THE PROCEDURE THE RFC WAS RUNNING ON AC POWER. THE RFC WAS REPLACED WITH ANOTHER DEVICE DURING USE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE AFFECTED ROTAFLOW CONSOLE WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE COULD BE CONFIRMED. THE MCP00702755#BATTERY PACK FOR RFC (ARTICLE NUMBER 701017188) HAS BEEN REPLACED. AFTER THE REPLACEMENT OF THE BATTERY THE DEVICE WAS WORKING AS INTENDED. THE FAILURE MODE "BATTERY NOT CHARGING" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO THE ROTAFLOW RISK MANAGEMENT FILE. BATTERY POWER FAILURE E.G.: 1. DEFECT BATTERIES 2. USER FORGOT RECHARGE THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2022-12-27 AND DURING THE PERIOD OF 2017-04-01 TO 2022-12-27 DOES NOT SHOW ANY NON-CONFORMITY 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 IN QUESTION WAS PRODUCED IN 2017-04-01. 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 / 15. 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 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 CHINA. IT WAS REPORTED THAT THE BATTERY OF THE ROTAFLOW CONSOLE (RFC) WILL NOT BE CHARGED. IT WAS NOTICED DURING PATIENT TREATMENT. DURING THE PROCEDURE THE RFC WAS RUNNING ON AC POWER. THE RFC WAS REPLACED WITH ANOTHER DEVICE DURING USE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2725975 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706291#ROTAFLOW PUMP MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown