BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER

    MDR report key: 1963111 · Received January 18, 2011

    Report

    Report Number
    2050012-2011-00137
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND A SECOND QUAD RING ON THE CO2 REFERENCE ELECTRODE CAUSING IMPROPER SEAL. THE FSE REMOVED ALL OF THE ELECTRODES, CLEANED THE FLOW CELL, AND REINSTALLED ALL ELECTRODES PROPERLY. THE FSE ALSO PERFORMED THE NECESSARY ALIGNMENTS ON THE SAMPLE WHEEL THAT WERE MISALIGNED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT CARBON DIOXIDE (CO2) WAS LEAKING FROM THE CO2 MEASURING ELECTRODE WHERE IT THREADS INTO THE FLOW CELL IN THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER. NO OPERATOR EXPOSURE WAS NOTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1