BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2241836 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05091
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) GENERATED A SERVICE REQUEST. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND REMOVED VALVE CONNECTORS AND CLEANED WITH THE CONTACT CLEANER. FSE INSPECTED ALL BOARDS AND A BURNT SPOT WAS FOUND ON THE MMC (MASTER MOTION CONTROL) BOARD ON THE ISE SIDE. FSE ORDERED A NEW MMC BOARD AND PINCH VALVES AND RETURNED ON-SITE (B)(6) 2011 AND INSTALLED THE MMC BOARD AND MOTOR DRIVER FOR ISE. FSE ALSO REPLACED ISE VALVES THAT WERE SHORTED DUE TO A POSSIBLE SPILL. THE INSTRUMENT WAS PRIMED AND ISE WAS OBSERVED FOR VALVE FLOW AND NO PROBLEMS WERE OBSERVED. CALIBRATION WAS ALSO PERFORMED WITH NO ISSUES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING AN ELECTRICAL SMELL AND ALSO REPORTED THAT THE ELECTROLYTE INJECTION CUP (EIC) IN THE SYNCHRON CX5 DELTA CLINICAL SYSTEM WAS OVERFLOWING. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1