BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10792320 · Received November 5, 2020

    Report

    Report Number
    8010762-2020-00375
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Report Date
    November 5, 2020
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GETINGE SERVICE TECHNICIAN WAS SENT FOR REPAIR. WORK PERFORMED ON 2020-10-12. ACCORDING TO SERVICE REPORT (B)(4) THE UNIT WAS NOT IN EMERGENCY MODE AND THE ROTARY KNOB WAS STILL ACTIVE (COULD BE ADJUSTED). A FULL SYSTEM TEST WAS PERFORMED, BUT THE ISSUE COULD NOT BE REPRODUCED. THERE WERE NO ENTRIES IN THE LOGS THAT WOULD INDICATE TOUCH PANEL FAILURE. DUE TO THAT FACT THE UNIT WAS NOT RELEASED FOR CLINICAL USE. FOR FURTHER INSPECTION THE UNIT WAS SENT TO THE GETINGE NATIONAL REPAIR CENTER. WORK PERFORMED ON 2020-10-19, 2020-10-20 AND 2020-10-22. ACCORDING TO SERVICE REPORT (B)(4) IT COULD BE CONFIRMED THAT THE DISPLAY LOCKED UP. IT HAD TO BE REPLACED WITH THE CH USER INTERFACE HARDWARE UPDATE KIT SN (B)(4). AFTER REPAIR AND MAINTENANCE THE DEVICE WAS TESTED AS PER SERVICE MANUAL. THE UNIT PASSED ALL TESTS. NOTE: THE VENOUS BUBBLE SENSOR WAS DEFECTIVE. THAT ISSUE WILL BE HANDLED UNDER COMPLAINT ID (B)(4). THUS THE REPORTED FAILURE COULD BE CONFIRMED. THE ROOT CAUSES FOR THE REPORTED FAILURES TO THE CARDIOHELP TOUCH PANEL IS NOT RESPONDING IS A KNOWN FAILURE. THE RISK IS MITIGATED IN THE CARDIOHELP RISK ANALYSES, CHAPTER H1.1.3.18. 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 AS PART OF THE CARDIOHELP USER INTERFACE HARDWARE UPDATE KIT (MATERIAL#70107.3922) IN SEPTEMBER, 2019. REGARDING TO THE REPLACEMENT OF THIS PART A SERVICE BULLETIN (ISSUE 82 / 2019-09-25) WAS ALREADY PROVIDED. 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 · 1

    THE CUSTOMER REPORTED THAT THE CARDIOHELP TOUCH PANEL BECAME UNRESPONSIVE WHILE IN USE ON A PATIENT, NO PATIENT HARM WAS REPORTED. ON 2020-10-27 NEW INFORMATION RECEIVED THAT THE CUSTOMER SWAPPED THE UNIT DURING PATIENT TREATMENT. COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260860 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ CARDIOHELP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1