BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 14652874 · Received June 10, 2022

    Report

    Report Number
    8010762-2022-00216
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    June 8, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOHELP HAS VENOUS BUBBLE SENSOR ERRORS (TECHNICAL ERROR MESSAGE "VENOUS BUBBLE SENSOR DEFECTIVE"). THE FAILURE OCCURRED DURING TREATMENT. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-06-09/20/23. THE FST RUN THE UNIT FOR ONE WEEK WITHOUT ANY ERROR MESSAGE. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THEREFORE THE VENOUS BUBBLE SENSOR WAS NOT EXCHANGED AND BEING USED FURTHER BY THE CUSTOMER. ACCORDING TO THE LOGFILE ANALYSIS THE ERROR MESSAGE "VENOUS BUBBLE SENSOR DEFECTIVE" OCCURRED MULTIPLE TIMES. NO EXACT ROOT CAUSE COULD BE DETERMINED AS THE FAILURE IS NOT REPRODUCIBLE AND THE SENSOR WAS NOT EXCHANGED. HOWEVER, ACCORDING TO THE RISK FILE V24 FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: WRONG BUBBLE SENSOR INFORMATION DUE TO: BUBBLE SENSOR DISTURBED. ENVIRONMENTAL INFLUENCES (ATMOSPHERIC PRESSURE, TEMPERATURE, HUMIDITY, EMI, OVERVOLTAGE). THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-06-10 FOR THE PERIOD OF 2017-07-20 TO 2022-06-08 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 2017-07-20. BASED ON THE RESULTS THE REPORTED FAILURE "ERROR MESSAGE: VENOUS BUBBLE SENSOR DEFECTIVE" COULD BE CONFIRMED BUT IS NOT REPRODUCIBLE. 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. 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 CARDIOHELP HAS VENOUS BUBBLE SENSOR ERRORS (TECHNICAL ERROR MESSAGE "VENOUS BUBBLE SENSOR DEFECTIVE"). THE FAILURE OCCURRED DURING TREATMENT. 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
    679628 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown