BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2233530 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03231
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE FOUND THAT THE WASH TOWER VALVE WAS NOT RESPONDING TO SOFTWARE COMMANDS. THE FSE REPLACED THE WASH TOWER VALVE AND VERIFIED VACUUM SYSTEM PERFORMANCE. NO ISSUES WERE NOTED. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT A FLUID LEAK FROM THE ACCESS 2 PORTION OF THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPORTED OBTAINING "VACUUM OVER LIMIT" ERRORS AND THE LEAK WAS FROM THE WASH TOWER AREA. NO EFFECT TO PATIENTS OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1