BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 3862175 · Received March 4, 2014

    Report

    Report Number
    8010762-2014-00221
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE HCU30 UNIT WAS INVESTIGATED BY A MAQUET FIELD SERVICE TECHNICIAN. THE RETURN TANK VALVE AND THE CARDIOPLEGIA STOP VALVE WERE FOUND TO BE CORRODED. BOTH VALVES WERE REPLACED. FUNCTIONAL TESTING WAS PERFORMED AND PASSED. THE UNIT WAS RUN THROUGH THE CLEANING CYCLE WITH NO ISSUE AND RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE UNIT WAS IN THE CLEANING MODE IT BEGAN TO EMIT A BURNING SMELL. THE UNIT WAS UNPLUGGED FROM THE WALL. NO PATIENT INVOLVEMENT. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130025 MAQUET HCU30 DEVICE HCU30 100V-120V DWC MAQUET CARDIOPULMONARY AG C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA