BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 12340939 · Received August 19, 2021

    Report

    Report Number
    8010762-2021-00457
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    August 9, 2021
    Report Date
    December 22, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THE ERROR MESSAGE "HEAD ERROR" DISPLAYED ON THE PUMP. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ONSITE AND INVESTIGATED THE UNIT IN QUESTION ON 2021-08-18. THE FST COULD CONFIRM THE REPORTED FAILURE AND REPLACED THE SPARE PART KIT HL20 MOTOR. THE SYSTEM WAS CHECKED ACCORDING TO FACTORY¿S SPECIFICATION AND ALL TESTS PASSED. THE DEVICE WAS PUT BACK IN USE. THE AFFECTED PART WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. HOWEVER THE REPORTED FAILURE "HEAD ERROR" WAS INVESTIGATED IN A PREVIOUSLY COMPLAINT AND THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A DEFECTIVE TACHOMETER OF THE MOTOR. AS A RESULT, THE MOTOR CONTROL BOARD DOES NOT READ HOW FAST THE MOTOR IS ROTATING AND THE SPEED CONTROL DOES NOT WORK. THUS THE REPORTED FAILURE "HEAD ERROR" COULD BE CONFIRMED. THE PRODUCT IN QUESTION WAS PRODUCED IN 2005-09-02. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2005-09-02 TO 2021-08-19 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 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. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ERROR MESSAGE "HEAD ERROR" DISPLAYED ON THE PUMP. COMPLAINT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239913 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown