BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 17215532 · Received June 28, 2023

    Report

    Report Number
    8010762-2023-00314
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Report Date
    June 28, 2023
    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

    IT WAS REPORTED THAT INTERNAL PRESSURE IS NOT TRANSMITTED FROM OXY TO CARDIOHELP (DUE TO DEFECTIVE HLS CABLE). NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FAILURE OCCURRED DURING MAINTENANCE. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. THE CONNECTION CABLE FOR INTERNAL SENSORS WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES OF THE REPORTED CARDIOHELP WERE REVIEWED AND NO ERROR MESSAGE WAS DISPLAYED ON THE DATE OF EVENT. FURTHER, IT WAS CONFIRMED BY FST THAT NO VISIBLE DAMAGES WERE FOUND ON THE CONNECTION CABLE FOR INTERNAL SENSORS. 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 RISK ANALYSIS V24 FOLLOWING ROOT CAUSES CAN ALSO LEAD 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, V2.4, CHAPTER 6.1 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. FURTHER THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. ACCORDING TO THE INSTRUCTION FOR USE (CARDIOHELP, CHAPTER 5.3 "CONNECTION THE SENSORS") IT IS STATED TO ENSURE THAT THE CONNECTED SENSORS ARE NOT DEFECTIVE AND TO NOT USE, IF THERE IS A VISIBLE DAMAGE. THE DEVICE WAS MANUFACTURED ON 2020-08-26. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-06-19 FOR THE PERIOD OF 2020-08-26 TO 2023-06-13. 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. BASED ON THE RESULTS THE REPORTED FAILURE "INTERNAL PRESSURE IS NOT TRANSMITTED " 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 PRESSURE INT IS NOT TRANSMITTED FROM OXY TO CARDIOHELP (DUE TO DEFECTIVE HLS CABLE). THE FAILURE OCCURRED DURING MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159082 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown