BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1993869 · Received February 16, 2011

    Report

    Report Number
    2050012-2011-00463
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CUSTOMER TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER TO POWER DOWN AND TO REBOOT THE SYSTEM. THE SYSTEM BOOTED PROPERLY AND NO FURTHER LEAKS WERE OBSERVED, BUT THE SYSTEM COMPRESSOR FAILED TO STAY ON. FIELD SERVICE ENGINEER REPLACED COMPRESSOR, VALVES, AND SET THE PRESSURE SETTINGS. THE FSE PRIMED THE INSTRUMENT 30 TIMES WITHOUT ERRORS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERROR MESSAGES AND A LEAKAGE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER RECEIVED LOW PRESSURE AIR SUPPLY LOW ERROR MESSAGES AND WASH DILUTION WAS POURING OUT. THE SYSTEM DID NOT RESPOND TO STOP/HOME COMMAND. NO FUME WAS PRODUCED AND THE CUSTOMER WAS NEITHER HARMED NOR NEEDED MEDICAL TREATMENT FROM EXPOSURE TO LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1