BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 18835931 · Received March 5, 2024

    Report

    Report Number
    8010762-2024-00114
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 18, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT LEAKAGE TEST FAILED. THE FAILURE OCCURRED DURING SERVICE. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON 2024-03-14. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. A SIMILAR FAILURE OF THE PATIENT LEAKAGE TEST WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING (LCE) ON 2023-08-11. THE EXCEEDING OF THE VALUE LIMIT AFFECTS ONLY THE SENSOR PANEL DA0, IN WHICH A HIGHER CAPACITOR VALUE WAS INSTALLED. THIS COMPLAINT IS IN SCOPE OF FSCA# 881841 (ONGOING). ACCORDING 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. BASED ON THE RESULTS THE REPORTED FAILURE "PATIENT LEAKAGE TEST FAILED" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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 PATIENT LEAKAGE TEST FAILED. THE FAILURE OCCURRED DURING SERVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID# (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477502 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown