BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX CLINICAL SYSTEM

    MDR report key: 1897144 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01261
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI HOTLINE WORKED WITH CUSTOMER TO CLEAN OUT A CLOT IN THE EIC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING THE ELECTROLYTE INJECTION CUP (EIC) NOT DRAINING AND OVERFLOWING ON THE 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1