BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2080751 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01533
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE REQUEST WAS GENERATED FOR THIS EVENT. CUSTOMER WAS TO CALL BACK IF CONTINUED TO SEE PROBLEMS. AS OF (B)(6) 2011, CUSTOMER HAD NOT CALLED CTS TO REPORT ANY FURTHER ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SUPPORT (CTS) AND REPORTED THAT THEIR ELECTROLYTES ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS WERE FAILING CALIBRATION. UPON TROUBLESHOOTING THE CALIBRATION FAILURE, IT WAS DETERMINED THAT A LEAK EXISTED WHICH THE CUSTOMER OBSERVED COMING FROM THE OVERFLOW TRAY UNDERNEATH THE ISE MODULE; CUSTOMER WAS UNABLE TO DETERMINE THE EXACT SOURCE OF LEAK. AFTER INSPECTING THE ISE MODULE MORE CLOSELY, IT WAS FOUND THE ISE BUFFER LINE WAS DETACHED FROM THE RATIO PUMP; CUSTOMER RECONNECTED THE LINE AND PRIMED INSTRUMENT; NO FURTHER LEAKING OBSERVED. 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 SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1