BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX CLINICAL SYSTEM

    MDR report key: 1882877 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01071
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE WASTE LINES, CLEANED WASTE CANISTER AND FLUSHED WITH BLEACH.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A FLUID LEAK ON THE FLOOR. CUSTOMER FOUND THE WASH STATION WASTE LINES CLOGGED TO WASTE CANISTER HAD CAUSED THE LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1