BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 CE

    MDR report key: 2132942 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02292
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K926060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. FLUID APPEARS TO BE BACKING UP IN LINE 18 LARGE DRAIN TUBE. CTS HAD CUSTOMER RUN THE ISE PRIME AND VERIFIED DRAIN FUNCTION, BUT COULD NOT REPRODUCE THE LEAK, AND INSTRUMENT RESUMED NORMAL OPERATION. CUSTOMER IS TO CALL BACK IF LEAK COMES BACK. NO FURTHER LEAKING HYDRO WAS FILED AS OF (B)(4) 2011. SERVICE WAS NOT DISPATCHED. NO CLEAR ROOT CAUSE WAS IDENTIFIED FOR THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REPORTING THAT FLUID IS LEAKING FROM LINE 18 AT FITTING ON DRAIN ASSEMBLY IN SYNCHRON CX5 CE ANALYZER.NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 CE CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 CE NA

    Patients

    Seq Age Sex Outcome Treatment
    1