BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 15274180 · Received August 23, 2022

    Report

    Report Number
    8010762-2022-00336
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 8, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE TECHNICIAN WILL INVESTIGATE THE AFFECTED CONNECTION CABLE FOR INTERNAL SENSORS. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WAS AN INTERMITTENT LOSS OF PRESSURE READINGS. THE FAILURE OCCURRED DURING ROUTINE MAINTENANCE. A GETINGE SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2022-08-12 AND 2022-08-17. THE CONNECTION CABLE FOR INTERNAL SENSORS WAS REPLACED. 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 TWISTED, BUT NO VISIBLE DAMAGE. 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 V24 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 DEVICE WAS MANUFACTURED ON 2020-12-02. THE DEVICE HISTORY RECORD (DHR) OF THE CARDIOHELP (MATERIAL: 701072780, SERIAL: (B)(6) ) WAS REVIEWED ON 2022-08-22. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "INTERMITTENT LOSS OF PRESSURE READINGS" 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

    THE EVENT OCCURRED IN USA DURING ROUTINE MAINTENANCE. INTERMITTENT LOSS OF PRESSURE READINGS FROM HLS WAS REPORTED. NO HARM TO ANY PERSON HAS BEEN REPORTED. ONETRACK 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
    2102235 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown