BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 18766137 · Received February 23, 2024

    Report

    Report Number
    8010762-2024-00101
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 16, 2024
    Report Date
    March 19, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOHELP IS NOT DETECTING FLOW. THE TIME OF OCCURRENCE COULD NOT BE PROVIDED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2024-02-20. THE FAILURE COULD BE REPLICATED AND THE FLOW/BUBBLE SENSOR WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ANOTHER FLOW/BUBBLE SENSOR WITH A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING (LCE) ON 2023-01-27. THE FLUCTUATING OF THE ZERO FLOW COULD BE REPRODUCED. IN SPECIFIC PAIRING OF THE FLOW/BUBBLE SENSOR WITH THE SENSOR PANEL, FLUCTUATIONS CAN BE OBSERVED DUE TO A NEW DIGIFLOW-MINI SINCE END OF 2019. FURTHER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE (DMS# 2021972) THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: - BUBBLE SENSOR DISTURBED. ACCORDING TO THE INSTRUCTION FOR USE (IFU) CHAPTER 5.3.1 "CONNECTING THE COMBINED FLOW/BUBBLE SENSOR" THE BUBBLE MONITORING FUNCTION TEST AND FLOW OFF-SET CALIBRATION HAS TO BE PERFORMED BEFORE EVERY USE. THUS A DEFECTIVE FLOW/BUBBLE SENSOR SHOULD BE DETECTED PRIOR TO USE, DURING PRIMING. IN ADDITION AS THE CARDIOHELP INCLUDES PRESSURE SENSORS AND A VENOUS PROBE IT IS ABLE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. IN THE IFU CHAPTER 6.4.4 "USING THE EMERGENCY DRIVE WITH THE DISPOSABLE HLS RETAINER" IS STATED THAT THE EMERGENCY DRIVE CAN BE USED TO MANUALLY CONTROL THE BLOOD FLOW IN CASE OF A FAILED CARDIOHELP. REFERRING TO THE IFU OF THE CARDIOHELP CHAPTER 10 "CLEANING AND DISINFECTION", THE CABLES AND THE WHOLE DEVICE SHOULD BE CLEANED AFTER EACH USE TO REMOVE SOILING OR RESIDUAL BLOOD. FURTHERMORE, IN CHAPTER 5.3 "CONNECTING THE SENSORS" IT IS STATED THAT THE SENSORS MUST BE KEPT CLEAN. THE DEVICE WAS MANUFACTURED ON 2020-06-24. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-02-26 FOR THE PERIOD OF 2020-06-24. TO 2024-02-16. 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. BASED ON THE RESULTS THE REPORTED FAILURE "NOT DETECTING FLOW" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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

    A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. THE FAILURE COULD BE REPLICATED AND THE FLOW/BUBBLE SENSOR WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A FOLLOW UP WILL SUBMITTED WHEN ADDITIOL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOHELP IS NOT DETECTING FLOW. THE INSTANCE OF TIME WAS NOT PROVIDED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228838 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown