BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2150006 · Received July 5, 2011

    Report

    Report Number
    2050012-2011-02835
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4)2011. FSE FOUND THAT THE Y FITTING WAS BROKEN ON ONE CONNECTION PORT AND REPLACED THE Y FITTING AND ALL TUBING ON THE NO FOAM BOTTLE. THE INSTRUMENT WAS PRIMED 5 TIMES WITH NO FURTHER LEAKING OBSERVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A NO FOAM LEAK IN THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE NO FOAM TUBING CAME OFF OF THE Y CONNECTOR FITTING. THE CUSTOMER REATTACHED THE TUBING AND IT NO LONGER APPEARED TO BE LEAKING. THE OPERATOR SLIPPED ON THE WET FLOOR BUT WAS NOT INJURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1