BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2152793 · Received July 7, 2011

    Report

    Report Number
    2050012-2011-02883
    Event Type
    Malfunction
    Date Received
    July 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) PERFORMED TROUBLESHOOTING OVER THE PHONE WHICH REVEALED THAT A LINE AT THE FLOWCELL WAS DISCONNECTED. THE CUSTOMER RESEATED TUBING. THE CUSTOMER ALSO PRIMED ISE MODULE AND DISASSEMBLED THE EIC (ELECTROLYTE INJECTION CUP) AND CHECKED FOR OBSTRUCTIONS. NO OBSTRUCTIONS WERE FOUND. THE CUSTOMER THEN REMOVED THE EIC VALVES AND CLEANED AND FORCED AIR INTO THE PORTS, REASSEMBLED, HOMED AND PRIMED THE SYSTEM AFTER WHICH A LINE CAME OFF. THE MODULAR CHEMISTRY (MC) DRIP TRAY WAS FULL AND WAS LEAKING ONTO THE FLOOR. THE CUSTOMER DISABLED THE ISE MODULE AND REQUESTED A SERVICE VISIT. THE SERVICE VISIT WAS CANCELLED BY THE CUSTOMER ON (B)(4) 2011. PER CUSTOMER, THEY WERE ABLE TO RESOLVE THE ISSUE AND WERE ABLE TO START USING THE INSTRUMENT. NO DETAILS WERE PROVIDED BY THE CUSTOMER ON WHAT RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT ELECTROLYTES WERE FAILING CALIBRATION ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM AND THERE WAS A LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1