BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5CE CHEMISTRY ANALYZER

    MDR report key: 1829806 · Received September 9, 2010

    Report

    Report Number
    2050012-2010-00734
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ONTO LOCATION AND IDENTIFIED THE ROOT CAUSE OF THE LEAK TO BE IMPROPERLY SEALED SAMPLE AND REAGENT SYRINGES INTO THE 3-WAY T-VALVE. FSE TIGHTENED THE SYRINGES, WHICH RESOLVED THE ISSUE. UPON REOCCURRENCE, THE HARDWARE FAILURES COULD CAUSE ERRONEOUS RESULTS ON ANY CHEMISTRIES AND PATIENT TREATMENT AND/OR OPERATOR SAFETY IS LIKELY TO BE IMPACTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A LEAK FROM THE HYDROPNEUMATICS THAT WAS CAUSED BY LOOSE SAMPLE AND REAGENT SYRINGES IN THE SYNCHRON CX5CE CHEMISTRY ANALYZER. THIS EVENT COULD POTENTIALLY CAUSE A SHORT SAMPLE/REAGENT DELIVERY OR DILUTE THE SAMPLE/REAGENT DUE TO THE DRIPPING. NO PATIENT RESULTS WERE GENERATED DURING THIS EVENT, THEREFORE, NO TREATMENT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5CE CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5CE NA

    Patients

    Seq Age Sex Outcome Treatment
    1