BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER UNIT

    MDR report key: 12770270 · Received November 8, 2021

    Report

    Report Number
    8010762-2021-00592
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    October 22, 2021
    Report Date
    February 21, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HCU 30 TURNED OFF DURING PATIENT TREATMENT WITH A BURNING SMELL. THE DEVICE HAS BEEN EXCHANGED DURING PATIENT TREATMENT. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ON SITE FOR FURTHER INVESTIGATION. THE FST CONFIRMED THE FAILURE. ACCORDING TO THE FST THE DEVICE DID NOT HAVE LEAKAGE OR ERROR MESSAGE DISPLAYED. THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON DECEMBER 2020. THE FST HAS CONFIRMED THAT A SHORT CIRCUIT WAS CAUSED BY A BROKEN WIRE JACKET IN THE POWER SUPPLY UNIT. THE SHORT CIRCUIT HAS CAUSED THE DEVICE TO TURN OFF. THE MOST PROBABLE ROOT CAUSE FOR THE WIRE JACKET TO BE BROKEN IS THE AGING OF THE DEVICE. IT HAS BEEN DECIDED TO NOT REPAIR DUE TO AGING OF THE DEVICE. THE HCU 30 HAS BEEN PHASED OUT SINCE THE END OF 2010. THE TECHNICAL SUPPORT, IN-HOUSE REPAIRS, AS WELL AS SPARE PARTS SUPPLIES HAVE BEEN DISCONTINUED IN 2017. THE DEVICE IS TAKEN OUT OF USE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-10-26 FOR THE PERIOD OF 2004-11-04 TO 2021-10-23. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION ON MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT IN QUESTION WAS PRODUCED IN 2004-11-04. IF SIGNIFICANT INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED AND NECESSARY STEPS WILL BE INITIATED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM. ADDITIONAL INVESTIGATIONS, OR CORRECTIVE ACTIONS, WILL BE IMPLEMENTED IN THE EVENT OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    FURTHER INVESTIGATION IS ON-GOING. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT (B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4). IT WAS REPORTED THAT THE HCU 30 HAD A BURNING SMELL AND IT TURNED OFF DURING CLINICAL USE. THE MACHINE WAS REPLACED DURING PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666015 HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC MAQUET CARDIOPULMONARY GMBH HCU 30

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose