BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 20454183 · Received October 15, 2024

    Report

    Report Number
    8010762-2024-0000493
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    October 11, 2024
    Report Date
    February 17, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW CONSOLE) HAS BEEN MANUFACTURED ON 2015. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN SOUTH KOREA. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE WAS UNEXPECTED TURNED OFF, WITHOUT ANY ERROR MESSAGE OR ALARM, WHILE OPERATING ON A PATIENT. THE DEVICE WAS EXCHANGED WITH A BACK-UP DEVICE AND CONTINUED THE SUPPORT OF THE PATIENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGED DURING USE AND THE UNEXPECTED PUMP STOP A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN INVESTIGATED THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) AND REPRODUCED THE REPORTED FAILURE "UNEXPECTED PUMP STOP". THE ON/OFF SWITCH WITH CABLING WAS DETECTED AS DEFECTIVE. THE SWITCH COULDN'T BE LOCKED IN THE "ON" POSITION. THE UNIT COULD ONLY BE TURNED ON BY PRESSING AND HOLD THE SWITCH. THE ON/OFF SWITCH WITH CABLING (ARTICLE NUMBER (B)(4)) HAS BEEN REPLACED. AFTER THE REPLACEMENT THE DEVICE WAS WORKING AS INTENDED AND IS BACK IN USE. THE ON/OFF SWITCH WITH CABLING (ARTICLE NUMBER (B)(4)) WAS INVESTIGATED BY THE GETINGE LIFE-CYCLE-ENGINEERING (LCE) AND A MALFUNCTION OF THE ON/OFF SWITCH WITH CABLING COULD BE CONFIRMED. THE SWITCH WAS SEND TO THE MANUFACTURER FOR FURTHER INVESTIGATION AND THE MOST PROBABLE ROOT CAUSE WAS DETERMIND AS WEAR AND TEAR. THE LOCKING MECHANISM, WAS WORN OUT WHICH LEAD TO THE REPORTED FAILURE. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2024-10-15 AND DURING THE PERIOD OF 2015-11-16 TO 2024-10-14 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 2015-11-16. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. FOR THE AFFECTED SERIAL NUMBER WITHIN THE TIMEFRAME OF THE SEARCH NO ADDITIONAL COMPLAINT WAS FOUND FOR THE SAME ISSUE. THE FOLLOWING IFU SECTION SHOULD BE FOLLOWED IN CASE OF A "PUMP STOP" HEART-LUNG SUPPORT SYSTEM ROTAFLOW SYSTEM/ 4.4 / EN / 15. CHAPTER 2.2.4 GENERAL PRECAUTIONARY MEASURES DURING USE IF THE PUMP STOPS DURING AN APPLICATION, THE BLOOD FLOW WILL BE INTERRUPTED AND SUPPLY TO THE PATIENT WILL CEASE. ELIMINATE THE CAUSE OF THE PUMP STOP AND START THE PUMP AGAIN AS SOON AS POSSIBLE. 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 SOUTH KOREA. IT WAS REPORTED THAT THE ROTAFLOW CONSOLE WAS UNEXPECTED TURNED OFF, WITHOUT ANY ERROR MESSAGE OR ALARM, WHILE OPERATING ON A PATIENT. THE DEVICE WAS EXCHANGED WITH A BACK-UP DEVICE AND CONTINUED THE SUPPORT OF THE PATIENT. THE DEVICE WAS CHECKED BY A MEDICAL ENGINEER IN THE HOSPITAL AND THE ON/OFF SWITCH WAS DETECTED AS DEFECTIVE. THE SWITCH COULDN'T BE LOCKED IN THE "ON" POSITION. THE UNIT COULD ONLY BE TURNED ON BY PRESSING AND HOLD THE SWITCH. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE EXCHANGED DURING USE AND THE UNEXPECTED PUMP STOP A REPORT IS REQUIRED. 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
    37123 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00706037#ROTAFLOW ENGLISH EU-PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention