BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEMS

    MDR report key: 2140249 · Received June 26, 2011

    Report

    Report Number
    2050012-2011-02641
    Event Type
    Malfunction
    Date Received
    June 26, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJC
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED WASTE CONNECTION LEAKING IS CORRODED. ON (B)(6) 2011 A BCI FIELD SERVICE ENGINEER (FSE) FOUND SEVERAL OLD AND CRACKED TUBES THAT WERE LEAKING. FSE REPLACED DRAIN TUBING FROM THE CX SIDE OVER THE HYDRO AND VERIFIED OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) HOTLINE IN REGARDS TO WASTE CONNECTION LEAK ON THE SYNCHRON CX9 ALX CLINICAL SYSTEMS. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJC BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1