BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 13677761 · Received March 7, 2022

    Report

    Report Number
    8010762-2022-00070
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    February 23, 2022
    Report Date
    August 8, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HL20 PUMP BELT BROKE DURING PATIENT TREATMENT. NO INJURY OR HARM REPORTED. A GETINGE FIELD SERVICE TECHNICIAN WILL BE SENT ONSITE FOR AN INVESTIGATION OF THE PUMP IN QUESTION. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HL20 PUMP DRIVE BELT HAS BROKEN DURING TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE CUSTOMER CONFIRMED THAT THE REPAIR WAS PERFORMED BY A THIRD PARTY SERVICE. THE REPLACED BELTS WERE NOT AVAILABLE FOR FURTHER INVESTIGATION. FURTHER THE BELTS WERE NOT REPLACED WITHIN THE 12 MONTHS INTERVAL AS DESCRIBED IN THE SERVICE MANUAL OF THE HL20. THE DEVICE IN QUESTION WAS MANUFACTURED ON 2008-09-13. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2008-09-13 TO 2022-04-14 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. THUS THE REPORTED FAILURE COULD BE CONFIRMED BUT MOST PROBABLY CAUSED BY THE USER. FURTHERMORE IN THE SERVICE MANUAL (CHAPTER 1.7 MAINTENANCE OVERVIEW) IT IS STATED THAT THE ROLLER PUMP MODULE BELT REPLACEMENT INTERVAL IS 12 MONTHS. THE USER WILL BE INFORMED BY THE SALES AND SERVICE UNIT ABOUT THE INVESTIGATION RESULTS. 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

    IT WAS REPORTED THAT THE HL20 PUMP BELT BROKE DURING PATIENT TREATMENT. NO INJURY OR HARM REPORTED. REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980193 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown