BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 18776220 · Received February 26, 2024

    Report

    Report Number
    8010762-2024-00104
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    February 8, 2024
    Report Date
    June 27, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING THE PERFORMANCE OF FSCA 881841 THE MEASURED VALUES OF THE PATIENT LEAKAGE TEST WERE OUT OF TOLERANCE FOR 4 CARDIOHELP DEVICES. THE FAILURE OCCURRED DURING MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. DUE TO THE RISK OF HARM TO A PATIENT BY LEAKING CURRENTS, A REPORT IS REQUIRED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE FAILURE COULD BE SOLVED BY ADJUSTING THE TEST MEASUREMENT ACCORDING TO SPECIFICATION. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO GETINGE TECHNICAL SUPPORT THE MOST PROBABLE ROOT CAUSE IS THAT THE MEASUREMENT WAS NOT CARRIED OUT AS PER SPECIFICATION ACCORDING TO IEC 62353. REFERRING TO THE INSTRUCTION FOR USE OF THE CARDIOHELP DEVICE (CHAPTER "CONNECTING EXTERNAL DEVICES (OPTIONAL)") IT IS STATED TO CHECK THE TOTAL LEAKAGE CURRENTS IF THE CARDIOHELP DEVICE WILL BE USED TOGETHER WITH OTHER MEDICAL DEVICES. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-06-26 FOR THE PERIOD OF 2015-12-01 TO 2024-02-08. 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 DEVICE WAS MANUFACTURED ON 2015-12-01. BASED ON THE RESULTS THE REPORTED FAILURE "OUT OF TOLERANCE VALUES DURING PATIENT LEAKAGE TEST" COULD BE CONFIRMED, BUT IS NOT RELATED TO A MALFUNCTION OF THE DEVICE. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE CARDIOHELP DEVICE AS A SINGLE EVENT (TIMEFRAME FROM 2023-02-08 TILL 2024-02-08). 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 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

    IT WAS REPORTED THAT DURING PERFORMING A FSCA (LEAKAGE CURRENTS AT THE SENSOR PANEL ARE ASSESSED WITH A NEW, REVISED VERSION OF THE TESTING TOOL BY A GETINGE SERVICE TECHNICIAN) THE MEASURED VALUES OF THE PATIENT LEAKAGE TEST WERE OUT OF TOLERANCE FOR 4 CARDIOHELP DEVICES. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323398 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP.I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown