BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2073383 · Received May 1, 2011

    Report

    Report Number
    2050012-2011-01292
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THERE WAS FLUID IN THE HYDRO COMPARTMENT AND UNDER THE INSTRUMENT. BCI CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING, AND RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING. SERVICE VISITED ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE HYDRO AND FOUND THAT THE FITTING ON THE NO FOAM BOTTLE ASSEMBLY WAS BROKEN. THE FSE REPLACED THE FITTING AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK FROM UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1