BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 15163110 · Received August 4, 2022

    Report

    Report Number
    8010762-2022-00303
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 2, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE ARTERIAL TEMPERATURE IS NOT READING ON THE SCREEN. THE FAILURE OCCURRED DURING EDUCATIONAL MEETING WITH THE CUSTOMER AND WAS CONFIRMED DURING INHOUSE SERVICE. THE TECHNICIAN VERIFIED THAT THE CONNECTION CABLE FOR DISPOSABLES WAS THE PROBLEM. ACCORDING TO THE LOG FILES ANALYSIS THE TECHNICIAN CONNECTED/DISCONNECTED THE CONNECTION CABLE FOR DISPOSABLES FOR TESTING MULTIPLE TIMES. AS THE FAILURE WAS NOT SOLVED, TWO CONNECTION CABLES FOR DISPOSABLES WERE SENT TO CUSTOMER FOR REPLACEMENT. THE CRITICAL TECHNICAL ERROR MESSAGES (DEVICE DEFECTIVE, PUMP DISPOSABLE ERROR-STOP) MENTIONED IN THE LOG FILES ARE LINKED TO THE EDUCATIONAL MEETING WITH THE CUSTOMER. THE CONNECTION CABLE FOR DISPOSABLES IS NOT AVAILABLE FOR INVESTIGATION. THUS, NO EXACT ROOT CAUSE COULD BE IDENTIFIED. HOWEVER, ANOTHER DISPOSABLE CONNECTION CABLE WITH A SIMILAR 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. WITHIN THE INSTRUCTION FOR USE OF THE CARDIOHELP (CHAPTER 6 ¿DURING THE APPLICATION¿) THE CARDIOHELP SHOULD ONLY BE OPERATED WITH ACTIVATED TEMPERATURE SENSORS AND TO ENSURE THAT THE WARNING AND ALARM LIMITS, AS WELL AS THE INTERVENTIONS, ARE SUITABLE FOR THE PATIENT AND CURRENT SITUATION. AN EXTERNAL TEMPERATURE SENSOR CAN BE USED. MOREOVER, 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 REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2022-08-30 FOR THE PERIOD OF 2011-05-01 TO 2022-08-03. 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 TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "ARTERIAL TEMPERATURE IS NOT READING ON THE SCREEN" 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 THE ARTERIAL TEMPERATURE IS NOT READING ON THE SCREEN. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    COMPLAINTNUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422193 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown