BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 20073900 · Received August 27, 2024

    Report

    Report Number
    8010762-2024-00420
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE BATTERY OF THE ROTAFLOW CONSOLE DOES NOT HOLD THE CHARGE. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE DEVICE WAS EXCHANGED DURING USE WITH ANOTHER DEVICE WITHOUT ANY NEGATIVE CONSEQUENCES. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE DURING PATIENT TREATMENT A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN WAS ON SITE FOR INVESTIGATION AND COULD CONFIRM THE REPORTED BATTERY ISSUE. THE BATTERY KIT (ARTICLE NUMBER 701017188) HAS BEEN REPLACED. THE DEVICE WAS TESTED AND PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO THE SPECIFICATIONS. THE DEVICE WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE ROOT CAUSE FOR THE BATTERY FAILURE COULD BE DETERMINED AS THE LIFETIME OF THE BATTERY WAS PASSED AND REPLACEMENT OVERDUE. THE AFFECTED BATTERY HAS NOT BEEN REPLACED FOR MORE THAN TWO YEARS. BASED ON THE THE GIVEN INFORMATION THE REPORTED FAILURE "BATTERY DOES NOT HOLD CHARGE" COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-07-23 FOR THE PERIOD OF 2005-09-02 TO 2024-07-19. IT 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 DEVICE WAS PRODUCED IN 2005-09-02. FOR THE AFFECTED SERIAL NUMBER WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. 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. 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW CONSOLE) HAS BEEN MANUFACTURED ON (2005). ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN ITALY. IT WAS REPORTED THAT THE BATTERY OF THE ROTAFLOW CONSOLE DOES NOT HOLD THE CHARGE. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE DEVICE WAS EXCHANGED DURING USE WITH ANOTHER DEVICE WITHOUT ANY NEGATIVE CONSEQUENCES. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGE DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939801 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH RFC 20-970 / ROTAFLOW CON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention