BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEM

    MDR report key: 2232165 · Received September 2, 2011

    Report

    Report Number
    2050012-2011-04757
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    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
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE PRIMED THE SYSTEM SEVERAL TIMES AND DID NOT OBSERVE AN ACTIVE LEAK. THE WASTE CANISTER WAS REMOVED AND THE FSE FOUND IT CLOGGED; THE CANISTER AND THE AREA INSIDE WAS CLEANED. THE FSE ALSO FOUND THE FIRST CANISTER ON THE LEFT WAS CLOGGED AND WAS CLEANED BY THE FSE. THE FSE REPLACED TWO WASTE LINES DUE TO BLOCKAGE. BLEACH WAS FLUSHED THROUGH THE WASTE SYSTEM. THE INSTRUMENT WAS PRIMED SEVERAL TIMES AND NO LEAKING WAS OBSERVED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES PRIOR TO RETURNING IT INTO SERVICE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS YELLOW FLUID UNDER THE HYDRO DRAWER WITHIN THE SYNCHRON CX9 ALX CLINICAL SYSTEM. CUSTOMER STATED SEVERAL HOURS LATER THERE WAS A SLOW DRIP NEAR THE INTAKE VALVE IN THE BACK OF THE DRAWER. CUSTOMER DESCRIBED THE LEAK AS ABOUT A QUARTER IN SIZE AND ORANGE IN COLOR. NO INJURY OR OPERATOR EXPOSURE 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