BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2252253 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05582
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) GENERATED A SERVICE REQUEST AND A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011. FSE REPLACED TUBES UNDER VALVE V12 IN THE HYDRO AREA AND ALSO REPLACED A QUICK CONNECT BARBED FITTING DUE TO BREAKAGE. THE INSTRUMENT WAS PRIMED AND QC WAS TESTED WITH NO ISSUES NOTED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THEY RECEIVED A MESSAGE THAT THE WASH CONCENTRATE RESERVOIR IN THE SYNCHRON LXI 725 CLINICAL SYSTEM WAS NOT FILLING. THE CUSTOMER OPENED THE HYDROPNEUMATIC AREA AND FLUID WAS OBSERVED ALONG THE BOTTOM. THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. THE WASH CONCENTRATE CANISTER AND WASH SOLUTION CANISTER WERE CHECKED AND THEY WERE BOTH FULL. THE CUSTOMER CLEANED THE SPILL WEARING PPE (PERSONAL PROTECTIVE EQUIPMENT) CONSISTING OF LAB COAT, GLOVES AND GLASSES. NO INJURY WAS REPORTED, MEDICAL ATTENTION WAS NOT SOUGHT AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX®I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1