BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12664032 · Received October 20, 2021

    Report

    Report Number
    8010762-2021-00564
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Report Date
    October 25, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE HOSPITAL REPORTED THAT THE ROTAFLOW CONSOLE (RFC) DISPLAYED THE ERROR MESSAGE ¿REFERENC ERROR¿, THEN THE MACHINE STOP PUMPING AND CANNOT BE USED. THE HOSPITAL REPLACED THE RFC WITH ANOTHER MACHINE, AND THE AFFECTED MACHINE IS NO LONGER IN USE. THERE WERE NO CASUALTIES. IT IS PRELIMINARILY JUDGED THAT THE FLOW MEASUREMENT BOARD AND POWER SUPPLY BOARD ARE DAMAGED. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH HAS BEEN REPORTED. THE ROTAFLOW CONSOLE (RFC) WITH S/N (B)(6) WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN ON 2021-10-21. THE TECHNICIAN CONFIRMED THE REPORTED FAILURE "REFERENC ERROR" AND REPLACED THE RFC POWER SUPPLY BOARD (ARTICLE NUMBER 701011675) AND THE RFC FLOW MEASURE BOARD (ARTICLE NUMBER 701011681). THE REPORTED FAILURE "REFERENC ERROR" WAS ALREADY INVESTIGATED BY THE GETINGE LIFE CYCLE ENGINEERING AND DETERMINED THE ROOT CAUSE AS A PARTIAL BREAKTHROUGH ON THE CAPACITOR C109 ON POWER SUPPLY BOARD, WHICH OVERLOADS THE VOLTAGE CONVERTER. THIS LED TO THE REPORTED ERROR. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON 2021-10-25. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED IN 2021-06-01. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "REFERENC ERROR" COULD BE CONFIRMED. 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

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE HOSPITAL USED THE ROTAFLOW CONSOLE AND THE MACHINE REPORTED THE ERROR MESSAGE ¿REFERENCE ERROR¿, THEN THE MACHINE STOPS PUMPING AND CANNOT BE USED ANY LONGER. THE HOSPITAL REPLACED THE MACHINE WITH ANOTHER ONE. THE AFFECTED MACHINE IS NO LONGER IN USE. THERE WERE NO CASUALTIES. IT IS PRELIMINARILY JUDGED THAT THE FLOW BOARD AND POWER BOARD ARE DAMAGED. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566527 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