BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 2122322 · Received June 13, 2011

    Report

    Report Number
    2050012-2011-02298
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOTLINE WORKED WITH THE CUSTOMER, BUT THEY COULD NOT FIND THE SOURCE OF THE LEAK. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011: THE FSE INSPECTED THE INSTRUMENT AND FOUND BROKEN PROBES ON THE WASH STATION. THE FSE REPLACED PROBES, CLEANED OTHER PROBES, CUVETTES, AND SPILL IN THE HYDRO. THE FSE CALIBRATED CHEMISTRIES, RAN QC, AND VERIFIED PROPER OPERATION. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND STATED THAT A BLUE COLORED FLUID WAS LEAKING ONTO THE FLOOR BENEATH THE HYDRO IN SYNCHRON CX9 ALX ANALYZER. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1