BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 2132937 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02290
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE FOUND THAT THE LEAKING IS COMING FROM TOP OF WASTE CANISTER. THE FSE FOUND BUCKET WITH A LOT OF GROWTH AND WASTE LINES CLOGGED. THE FSE CLEANED THE GROWTH IN THE WASTE BUCKET AND FLUSHED WASTE LINES WITH BLEACH. THE FSE PRIMED THE SYSTEM AND RAN SAMPLES WITH NO FURTHER LEAKS. THE CLOGGED WASTE LINES IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THEY RECEIVED "DILUTED WASH BOTTLE NOT FILLING AND LEAKING" ERROR, AND SYNCHRON CX9 ALX INSTRUMENT IS LEAKING. 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