BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2001982 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00573
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STOPPED THE INSTRUMENT AND CLEANED UP THE WASH. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING, HAD THE CUSTOMER HOME THE SYSTEM, AND THEN TO OBSERVE THE WASH CONCENTRATE BOTTLE. PER THE CUSTOMER, THE WASH BOTTLE IS NO LONGER OVERFLOWING BUT FLUID IS FILLING THE HYDRO TRAY FROM SOMEPLACE AND CUSTOMER CANNOT FIGURE OUT WHERE. CTS ADVISED THE CUSTOMER TO SHUTDOWN AND REBOOT THE INSTRUMENT. CUSTOMER STATED THAT SHUTDOWN/REBOOT STOPPED THE LEAKING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND INVESTIGATED THE SYSTEM, BUT COULD NOT FIND ANY ISSUES. FSE CLEANED THE CORRESPONDING VALVES AND RAN QC. PER THE FSE, HYDRO IS CURRENTLY PERFORMING NORMALLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT WHEN THE OPERATOR DISCOVERED THAT THE CANISTER WAS NOT FILLING AND THAT THE HIGH PRESSURE AIR SUPPLY WAS LOW ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM, THE OPERATOR OPENED THE INSTRUMENT DOOR AND FOUND THE HYDRO WAS FLOODED AND THE WASH CONCENTRATE WAS BUBBLING OUT OF THE BOTTLE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1