BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 14278087 · Received May 4, 2022

    Report

    Report Number
    8010762-2022-00146
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE SERVICE 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 CUSTOMER CREATED AIR IN THE LINE BUT THE BUBBLE INTERVENTION DID NOT STOP THE PUMP FROM PUMPING. THE INTERVENTION SYMBOL WAS PRESENT BUT THE PUMP DID NOT STOP. THE FAILURE OCCURRED DURING A WET LAB TRAINING. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE FST WENT ON SIDE AND COULD NOT REPRODUCE THE REPORTED FAILURE. ACCORDING TO THE RISK FILE V24 (DMS# 2021972) FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: BUBBLE INTERVENTION IS NOT WORKING/ WRONG INFORMATION DUE TO: WRONG BUBBLE SENSOR INFORMATION INFLUENCE DUE TO OTHER ULTRASONIC DEVICE BUBBLE SENSOR NOT PLUGGED BUT RECOGNIZED ENVIRONMENTAL INFLUENCES (ATHMOSPHERIC PRESSURE, TEMPERATURE, HUMIDITY, EMI, OVERVOLTAGE) ACCORDING TO THE INSTRUCTION FOR USE OF THE CARDIOHELP CHAPTER 5.3.2 CONNECTING THE BUBBLE SENSOR THE BUBBLE SENSOR HAS TO BE POSITIONED ON THE VENOUS SIDE, AT LEAST 30CM UPSTREAM OF THE BLOOD INLET OF THE DISPOSABLE. FURTHERMORE IN CHAPTER 6.2.4 BUBBLE MONITORING IT IS MENTIONED THAT AT A FLOW RATE OF LESS THAN 50 ML/MIN, IT IS POSSIBLE THAT THE VENOUS BUBBLE SENSOR WILL NOT DETECT ANY AIR BUBBLES PRESENT. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-05-03 FOR THE PERIOD OF 2019-07-11 TO 2022-04-28. 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 2019-07-11. BASED ON THE RESULTS THE REPORTED FAILURE "INTERVENTION WAS SET, BUT NO PUMP STOP OCCURRED" COULD NOT BE REPRODUCED AND IS NO DEVICE RELATED MALFUNCTION. 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 CUSTOMER CREATED AIR IN THE LINE BUT THE BUBBLE INTERVENTION DID NOT STOP THE PUMP FROM PUMPING. THE INTERVENTION SYMBOL WAS PRESENT BUT THE PUMP DID NOT STOP. THE FAILURE OCCURRED DURING A WET LAB TRAINING. 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
    1839958 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown