BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210823 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04485
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. CTS HAD THE CUSTOMER OPEN THE HYDROPNEUMATIC SYSTEM AND CUSTOMER REPORTED THAT THE WASH CONCENTRATE CANISTER ON THE RIGHT HAND SIDE WAS BUBBLING OUT OF THE TOP. CTS ASSISTED THE CUSTOMER TO MANUALLY FILL DI (DEIONISED) WATER RESERVOIR AND STOP AND HOME THE SYSTEM. THIS RESOLVED THE ISSUE. NO SERVICE VISIT WAS NEEDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT LIQUID WAS BUBBLING FROM DILUTE WASH CANISTER IN THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1