BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 16276954 · Received February 1, 2023

    Report

    Report Number
    8010762-2023-00063
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 30, 2023
    Report Date
    August 2, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PRESSURE READING WERE UNSTABLE. THE FAILURE OCCURRED DURING TREATMENT. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-07-17. THE FAILURE COULD BE REPLICATED AND THE AFFECTED CABLE FOR INTERNAL SENSORS WILL BE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED FOR THE CARDIOHELP. THE LOG FILES FOR THIS EVENT WERE NOT PROVIDED. A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING. THE MOST POSSIBLE ROOT CAUSES FOR THE MISSING CONNECTION IS A BROKEN WIRE WITHIN THE CABLE, WHICH MOST LIKELY IS ORIGINATED FROM EXTERNAL FORCE, AS NO SIGNS OF AN OUTSIDE DAMAGE WERE VISIBLE. ACCORDING TO THE RISK ANALYSIS V24 OF THE CARDIOHELP DEVICE 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, V2.3, 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. ALSO IN 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 2021-03-01. THE DEVICE HISTORY RECORD (DHR) OF THE CARDIOHELP WAS REVIEWED ON 2023-03-01. 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 " PRESSURE READING UNSTABLE" 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PRESSURE READING WERE UNSTABLE DURING TREATMENT. THE TREATMENT HAS NOT BEEN STOPPED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775377 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown