BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 15824001 · Received November 18, 2022

    Report

    Report Number
    8010762-2022-00459
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 18, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE P-VEN (VENOUS PRESSURE) READING DID NOT WORK. THE FAILURE OCCURRED DURING PREVENTIVE MAINTENANCE. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-11-15. THE CABLE WAS NOT VISIBLE DAMAGED. THE CONNECTION CABLE FOR DISPOSABLES WAS REPLACED. THIS SOLVED THE FAILURE. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. FURTHERMORE A LOGFILE ANALYSIS WAS PERFORMED AND THE ERROR MESSAGE "P-VEN DEFECTIVE" OCCURRED. NO PUMP STOP WAS TRIGGERED. A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING (LCE) ON 2022-11-02. THE NATURE OF THE ERROR COULD BE TRACED BACK TO A MISSING ELECTRICAL CONNECTION WITHIN THE CABLE. THE ROOT CAUSE FOR THE MISSING CONNECTION IS A BROKEN WIRE WITHIN THE CABLE, WHICH IS ORIGINATED FROM EXTERNAL FORCE. ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.3, CHAPTER 7.1 PREPARATION AND INSTALLATION AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER 7.2 PRIMING THE SYSTEM) THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-11-17 FOR THE PERIOD OF 2017-05-17 TO 2022-11-15. 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 2017-05-17. BASED ON THE RESULTS THE REPORTED FAILURE "P-VEN READING FAILURE CAUSED BY A DEFECTIVE HLS CABLE " COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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 WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE P-VEN (VENOUS PRESSURE) READING DID NOT WORK. THE FAILURE OCCURRED DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231929 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown