BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2110826 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01957
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND WASH CONCENTRATE UNDER 4 VALVES. FSE REPLACED TUBING ON ALL FOUR VALVES AND HOMED THE INSTRUMENT. FSE PRIMED THE INSTRUMENT SEVERAL TIMES AND NOTICED WATER COMING OUT OF THE AIR BLEED LINE. FSE INSPECTED THE WASH SOLUTION CONTAINER AND FOUND THAT THE FLOAT SWITCH WAS NOT PLUGGED IN ALL THE WAY AND PLUGGED IT IN PROPERLY. FSE THEN PRIMED THE INSTRUMENT AND CHECKED THE OPERATION OF THE CUVETTE WASH MANIFOLD AND NOTED THAT THE MIDDLE WASH PROBE WAS NOT DISPENSING ANY FLUID. FSE REPLACED VALVE ON THE MANIFOLD, PRIMED THE CUVETTE WASH MANIFOLD AND IT DISPENSED FLUID PROPERLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK FROM THE HYDROPNEUMATIC AREA OF THE SYNCHRON LX20 PRO ANALYZER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1