BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2001961 · Received February 27, 2011

    Report

    Report Number
    2050012-2011-00563
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND THAT THE TUBING WHICH PLUGS INTO TOP OF NO FOAM BOTTLE WAS LOOSE. ADDITIONAL FLUID LEAKED AFTER THE CUSTOMER REMOVED TUBING FROM NO FOAM BOTTLE DURING PHONE CALL TO BCI CUSTOMER TECHNICAL SUPPORT. THE CUSTOMER CUT AND RE-FIT THE TUBING TO NO FOAM BOTTLE. THE CUSTOMER WAS INSTRUCTED TO CALL BACK IF THE ISSUE CONTINUED. AS OF 02/02/2011, THE CUSTOMER HAD NOT CALLED REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO OPERATOR EXPOSURE WAS NOTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    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