BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2150037 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02831
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CLEANED THE VACUUM ACCUMULATOR AND 2 NO FOAM VALVES. INSTRUMENT PRIMED 20 TIMES WITH NO ERRORS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK IN THE HYDRO AREA OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FROM AN UNKNOWN SOURCE. THE INSTRUMENT FLAGGED WITH HYDRO ERRORS AND THE HYDRO DRAWER CONTAINED A FOAMY LIQUID INSIDE. NO INJURY WAS REPORTED.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1