BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 11567206 · Received March 25, 2021

    Report

    Report Number
    8010762-2021-00208
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 23, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL FAILURE DESCRIPTION WAS THAT THE ROTAFLOW HAD A "BURNT SMELL AND THE PUMP STOPPED. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE DEVICE HAS BEEN EXCHANGED WITH A BACKUP DEVICE. NO PATIENT HARM OCCURRED. A GETINGE SERVICE TECHNICIAN WAS ON SITE TO REPAIR THE AFFECTED ROTAFLOW ON 2021-06-16. THE TECHNICIAN CONFIRMED THE REPORTED FAILURE. IN ADDITION THE TECHNICIAN FOUND THAT THE CHARGING AND BATTERY INDICATOR LIGHTS ARE NOT WORKING ANYMORE. THE TECHNICIAN REPLACED THE RFC (ROTAFLOW CONSOLE) POWER SUPPLY BOARD (MATERIAL #70101.1675). AFTER THE REPLACEMENT THE DEVICE IS WORKING AS INTENDED. THE DEFECT RFC POWER SUPPLY BOARD (MATERIAL #70101.1675) HAS BEEN REQUESTED FOR FURTHER INVESTIGATIONS AT OUR LIFE-CYCLE-ENGINEERING (LCE, PRODUCT SPECIALISTS). THE POWER SUPPLY BOARD HAS BEEN INVESTIGATED IN THE LCE ON 2021-06-01 AND FOLLOWING MOST PROBABLE ROOT CAUSE COULD BE DETERMINED: DURING THE VISUAL INSPECTION OF THE BOARD IT WAS FOUND THAT THE INTEGRATED CIRCUIT IC3 IS BURNT. THE DAMAGE TO THE IC3 CAN BE DIRECTLY RELATED TO THE DESCRIBED ISSUES. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE IS AN INTERNAL DEFECT OR SHORT CIRCUIT IN THE IC3. THE REASON FOR THAT COULD BE A WEAR OUT FAILURE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-06-21 FOR THE PERIOD OF 2016-01-18 TO 2021-06-21. 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 PRODUCT IN QUESTION WAS PRODUCED IN 2016-01-18. BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURE COULD BE CONFIRMED. 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. 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.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFER THE CUSTOMER SMELT A BURNT SMELL. THE ROTAFLOW THEN STOPPED AND COULD NOT BE SWITCHED BACK ON. THE DEVICE HAS BEEN EXCHANGED WITH A BACKUP DEVICE. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467583 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention