BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER UNIT HCU 30

    MDR report key: 10884742 · Received November 23, 2020

    Report

    Report Number
    8010762-2020-00397
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 18, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCU 30 WATER TEMPERATURE RISING SLOWLY DURING TREATMENT. ACCORDING TO THE SERVICE REPORT DATED ON 2020-11-11 THE FIELD SERVICE TECHNICIAN REPLACED THE ACTUATOR 24 V AC/DC 50/60 HZ (MATERIAL#70103.4052) AND THE 3-WAY VALVE (MATERIAL701020562). ALL FUNCTION TESTS PASSED. THE DEVICE IS BACK IN CLINICAL USE. SIMILAR COMPONENT "3 WAY VALVE" WAS ALREADY INVESTIGATED IN COMPLAINT (B)(4) ON 2018-04-27. WITH LIFE CYCLE ENGINEERING (LCE) INVESTIGATION REPORT NO.(B)(4): THE VALVE WAS STRONGLY POLLUTED ON THE INSIDE AND ON THE THREAD. FURTHERMORE THE VALVE HAD SEVERAL SCRATCHES ON THE OUTSIDE. THE PIN, WHICH IS RESPONSIBLE FOR OPENING AND CLOSING THE VALVE, COULD BE MOVED. HOWEVER IN THE BEGINNING MOVING THE PIN WAS MORE DIFFICULT. THIS INDICATES THAT THE PIN COULD HAVE BEEN BLOCKED BY THE POLLUTION. A WRONG SETTING OR A DEFECTIVE ACTUATOR CAN ALSO LEADS TO THE REPORTED FAILURE. THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED MALFUNCTION OF THE HCU 30 IS THE POLLUTION OF THE 3-WAY VALVE AND A WRONG SETTING OF THE ACTUATOR. THE DEVICE WAS PRODUCED IN 2003. THE REVIEW OF THE NON-CONFORMITIES DURING THE PERIOD OF 2003-01-01 TO 2020-12-15 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 CAN BE EXCLUDED. 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

    COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCU 30 HEATS UP VERY SLOWLY DURING TREATMENT. NO INDICATION OF ACTUAL OR POTENTIAL FOR HARM OR DEATH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349488 HEATER COOLER UNIT HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY GMBH HCU 30

    Patients

    Seq Age Sex Outcome Treatment
    1