BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2211022 · Received August 13, 2011

    Report

    Report Number
    2050012-2011-04458
    Event Type
    Malfunction
    Date Received
    August 13, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011. THE FSE OBSERVED THAT THE CAP PIERCER WASTE OVERFLOWED. THE FSE REMOVED THE CAP PIERCER BLADE AND REPLACED THE WICK. THE CAP PIERCER WASH STATION AND WASTE VALVE WAS CLEANED. THE FSE RAN 4 TUBES WITH CAP 3 TIMES AND ISSUES WERE OBSERVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A LEAK FROM A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE LEAK WAS UNDER THE CAP PIERCER. CUSTOMER TECHNICAL SUPPORT ASSISTED THE CUSTOMER IN DISABLING THE DEVICE. NO EFFECT TO PATIENT OR OPERATOR 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