BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 2767469 · Received October 1, 2012

    Report

    Report Number
    2050012-2012-01481
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT APPROXIMATELY 500 ML OF FLUID LEAKED FROM THE RIGHT SIDE OF THE SYNCHRON LXI 725 CLINICAL SYSTEM (LXI 725) AND ONTO THE FLOOR. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED BOTH CARTRIDGE CHEMISTRIES (CC) MIXER WASH STATIONS WERE OVERFLOWING INTO THE BOTTOM OF THE HYDRO ASSEMBLY. THE FSE FOUND THE OVERFLOWING WAS DUE TO AN OCCLUDED GRAVITY CANISTER PORT. THE FSE OBSERVED WHITE SUBSTANCE OF UNKNOWN MATERIAL. THE FSE CLEANED THE PORT AND DECONTAMINATED THE GRAVITY CANISTER WITH BLEACH. THE LXI 725 SYSTEM DRAINED WELL AND NO OVERFLOWING WAS OBSERVED AFTER THE REPAIRS. THE FSE ALSO PERFORMED PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1