BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12834151 · Received November 18, 2021

    Report

    Report Number
    8010762-2021-00613
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    November 15, 2021
    Report Date
    May 12, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT THE FLOW RATE DROPPED ON THE ROTAFLOW CONSOLE FROM 5L/MIN TO 0.5L/MIN EVEN THOUGH THEY DIDN'T TOUCH THE ROTARY KNOB. THE FLOW RATE DROPPED, APPARENTLY AFTER ROTAFLOW BUMPED INTO A HOSPITAL STAFF MEMBER WHILE MOVING THROUGH THE HOSPITAL. AFTER THE FLOW RATE DROPPED, THE EMERGENCY DRIVE WAS USED TO MAINTAIN CIRCULATION. SHORTLY AFTER THIS PROBLEM OCCURRED, IT WAS REPLACED WITH AN ECMO DEVICE FROM A DIFFERENT MANUFACTURER. NO HARM TO THE PATIENT HAS BEEN REPORTED. THE AFFECTED ROTAFLOW CONSOLE (RFC) WITH S/N 100052 WAS INVESTIGATED BY A GETINGE FIELD SERVICE TECHNICIAN AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE RFC WAS TESTED APPROXIMATELY 10 HOURS AND THE FLOW RATE WAS CONSTANT AND STABLE DURING THE TEST. THE DEVICE IS BACK IN USE. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "FLOW DROPPED" COULD NOT BE CONFIRMED. HOWEVER THE FAILURE MODE "FLOW DROPPED" CAN BE LINKED TO THE FOLLOWING MOST POSSIBLE ROOT CAUSES ACCORDING TO OUR RISK MANAGEMENT FILE. - ZERO FLOW CALIBRATION FAILED. - INCORRECT FLOW MEASUREMENT. - DEVICE USED OUT OF SPECIFICATION. - MALFUNCTION OF BUBBLE/FLOW SENSOR ELECTRONICS. - DRIED CONTACT GEL. - USER FORGOT RENEWING CONTACT GEL. - SENSOR NOT DETECTED ALTHOUGH SENSOR IS CONNECTED. - DEVICE USED OUT OF SPECIFICATION. - SOFTWARE ERROR. THE REVIEW OF THE NON-CONFORMITIES WAS PERFORMED ON 2021-11-18 AND DURING THE PERIOD OF 2017-09-16TO 2021-11-18 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 2017-09-16. 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.

    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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE FLOW RATE DROPPED ON THE ROTAFLOW CONSOLE FROM 5L/MIN TO 0.5L/MIN EVEN THOUGH THEY DIDN'T TOUCH THE ROTARY KNOB. THE FLOW RATE DROPPED, APPARENTLY AFTER ROTAFLOW BUMPED INTO A HOSPITAL STAFF MEMBER WHILE MOVING THROUGH THE HOSPITAL. AFTER THE FLOW RATE DROPPED, THE EMERGENCY DRIVE WAS USED TO MAINTAIN CIRCULATION. SHORTLY AFTER THIS PROBLEM OCCURRED, IT WAS REPLACED WITH AN ECMO DEVICE FROM A DIFFERENT MANUFACTURER. NO HARM TO THE PATIENT HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732963 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH MCP00703157#RFC 20-970 ROTAFLOW CONSOLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose