BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 14203114 · Received April 26, 2022

    Report

    Report Number
    8010762-2022-00127
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 16, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE TECHNICIAN WILL INVESTIGATE THE DEVICE. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE TOUCH WAS NOT RESPONDING AND WAS ALWAYS LOOSING THE CALIBRATION. THE FAILURE OCCURRED DURING TREATMENT. NO PATIENT HARM WAS REPORTED. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION IN APRIL 2022. AFTER RECALIBRATION OF THE TOUCH DISPLAY THE FAILURE DISAPPEARED. AFTER DEVICE LOST THE CALIBRATION AGAIN THE FST WAS ON SITE FOR INVESTIGATION AND REPAIR ON 2022-05-09. THE USER INTERFACE WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE FAILURE "TOUCH PANEL IS NOT RESPONDING/LOOSING CALIBRATION" HAS BEEN PREVIOUSLY ACKNOWLEDGED AND ACTIONS HAVE BEEN IMPLEMENTED TO AVOID THE RE OCCURRENCE. THE TOUCH PANEL FOIL (MATERIAL#70505.3579_REV.02) WHICH WAS USED FORMERLY SHOWED AN INCREASED RATE OF CONNECTION PROBLEMS. AS A SOLUTION FOR THAT A NEW TOUCH PANEL WAS IMPLEMENTED AND IS BUILT IN CARDIOHELP UNITS SINCE SEPTEMBER, 2019. ACCORDING TO THE RISK FILE V24 (DMS# 2021972) FOLLOWING ROOT CAUSE CAN LEAD TO THE REPORTED FAILURE: - LOST TOUCH CALIBRATION. THE CARDIOHELP HAS SEVERAL SAFETY FEATURES, THAT THE DEVICE CAN BE OPERATED, EVEN WHEN THE TOUCH SCREEN DOES NOT WORK ANYMORE. ALL-IMPORTANT ADJUSTMENTS CAN BE MADE BY USING THE ROTARY KNOB OR IF ALL OTHER THINGS DO NOT WORK BY ENGAGING THE EMERGENCY MODE TO KEEP UP THE BLOOD FLOW. FURTHER ACCORDING TO THE INSTRUCTION FOR USE (CARDIOHELP SYSTEM, CHAPTER 5.6.1 CHECK BEFORE EVERY APPLICATION) THE TOUCH SCREEN HAS TO BE CHECKED BEFORE USE. THE PRODUCT IN QUESTION WAS PRODUCED ON 2011-01-01. THE ROOT CAUSE FOR THIS ISSUE WAS ALREADY DETERMINED AS A QUALITY ISSUE AND A NEW TOUCH PANEL WAS IMPLEMENTED AS PART OF THE CH USER INTERFACE HARDWARE UPDATE KIT (MATERIAL#70107.3922) IN SEPTEMBER, 2019. BASED ON THE RESULTS THE REPORTED FAILURE "TOUCH NOT RESPONDING" 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TOUCHSCREEN IS NOT RESPONDING. THE CARDIOHELP WAS EXCHANGED DURING TREATMENT. NO HARM TO PATIENT 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
    1529595 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose