BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 15408125 · Received September 13, 2022

    Report

    Report Number
    8010762-2022-00369
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    September 7, 2022
    Report Date
    October 24, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CONNECTION CABLE FOR INTERNAL SENSORS WAS DEFECT CAUSING WRONG PRESSURE VALUES WHEN MOVED. THE FAILURE OCCURRED DURING MAINTENANCE. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-08-30. CUSTOMER WAS INSTRUCTED NOT TO USE THE DEFECT CONNECTION CABLE FOR INTERNAL SENSORS. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE TECHNICIAN THERE WERE SIGNS OF THE CABLE BEING KINKED AND IT WAS WORN OUT. ACCORDING TO THE LOG FILE ANALYSIS NO PUMP STOP WAS TRIGGERED BY THE WRONG PRESSURE VALUES DURING INSPECTION. ANOTHER CONNECTION CABLE FOR INTERNAL SENSORS WITH THE SAME FAILURE WAS INVESTIGATED BY GETINGE LIFE CYCLE ENGINEERING ON 2021-08-30. THE ROOT CAUSE FOR THE REPORTED MALFUNCTION 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 MOST LIKELY ORIGINATED FROM EXTERNAL FORCE. FURTHERMORE, ACCORDING TO THE RISK ANALYSIS FOLLOWING ROOT CAUSES CAN ALSO LINKED TO THE REPORTED FAILURE: A MECHANICAL DAMAGE E.G. DUE TO TOO HIGH FORCES DURING CONNECTION/ DISCONNECTION OF THE CABLE. BROKEN FIBER INSIDE THE CABLE. 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 2022-09-30 FOR THE PERIOD OF 2017-03-09 TO 2022-09-07. 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 2017-03-09. BASED ON THE RESULTS THE REPORTED FAILURE "CONNECTION CABLE FOR INTERNAL SENSORS WAS DEFECT" 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 THERE WAS A DEFECT CONNECTION CABLE FOR INTERNAL SENSORS. NO FURTHER INFORMATION WAS PROVIDED. 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
    2534607 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown