BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 14729980 · Received June 17, 2022

    Report

    Report Number
    8010762-2022-00226
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    June 10, 2022
    Report Date
    January 30, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-06-23. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-06-15 FOR THE PERIOD OF 2017-01-01 TO 2022-06-10. 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 2017-01-01. THE SENSOR PANEL WAS REQUESTED FOR INVESTIGATION. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE GETINGE FIELD SERVICE TECHNICIAN (FST) WAS UNABLE TO ZERO THE INTEGRATED PRESSURE VALUE P-ART. THE FAILURE OCCURRED DURING PREVENTIVE MAINTENANCE. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-06-23. THE SENSOR PANEL WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE LOGFILE ANALYSIS NO PUMP STOP OCCURRED DUE TO THE FAILURE. THE AFFECTED SENSOR PANEL WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING ON 2023-01-26 WITH FOLLOWING CONCLUSION: THE FAILURE COULD BE CONFIRMED. THE MOST PROBABLE ROOT CAUSE IS THAT THE WETTING OF THE SOCKET PLAN FROM THE HLS CONNECTOR AFFECTED THE MEASUREMENT VOLTAGES FOR THE ARTERIAL PRESSURE. THIS LEAD TO THE UNSTABLE VALUE CHANGES OF THE PRESSURE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-06-15 FOR THE PERIOD OF 2017-01-01 TO 2022-06-10. 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 2017-01-01. BASED ON THE RESULTS THE REPORTED FAILURE "UNABLE TO ZERO PRESSURE" 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 TECHNICIAN WAS UNABLE TO ZERO THE INTEGRATED PRESSURE VALUE P-ART. THE FAILURE OCCURRED DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON WAS REPORTED. (B)(4).

    Description of Event or Problem · 0

    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
    201908 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown