BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX DELTA CLINICAL SYSTEM

    MDR report key: 2402329 · Received January 6, 2012

    Report

    Report Number
    2050012-2011-08595
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 11, 2011
    Report Date
    December 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: WASTE SUMP. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT FOAM WAS COMING OUT OF BOTH WASH STATIONS OF THE SYNCHRON CX DELTA CLINICAL SYSTEM. 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) FOUND BACTERIAL GROWTH IN THE WASTE SUMP WHICH CREATED A BLOCKAGE AND RESULTING IN FLUID NOT DRAINING FROM THE WASH STATIONS PROPERLY. THE FSE CLEANED THE WASTE SUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX DELTA CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. CX9 ALX NA

    Patients

    Seq Age Sex Outcome Treatment
    1