BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 1969257 · Received January 24, 2011

    Report

    Report Number
    2050012-2011-00247
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING (TS) AND FOUND THAT ONE OF THE LINES ON THE EIC CAME OFF AND THAT THERE WAS FLUID AROUND THE COMPARTMENT. THE CTS ADVISED THE CUSTOMER TO CLEAN UP THE LEAK AND THE FLUSH THE EIC. THE CUSTOMER REINSTALLED THE LINES AND THE EIC. NO SERVICE WAS DISPATCHED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ELECTROLYTE INJECTION CUP (EIC) WAS OVER FILLING IN THE SYNCHRON CX9 ALX CLINICAL SYSTEM. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1