BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 PRO CLINICAL SYSTEM

    MDR report key: 3091939 · Received May 3, 2013

    Report

    Report Number
    2050012-2013-00310
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THE TUBING FROM THE ISE SIDE TO THE WASTE CONTAINER WAS LEAKING BACK AT FITTING TO SIDEWALL. THE FITTING THAT CONNECTS TO THE WASTE CONTAINER WAS PARTIALLY BLOCKED WITH WASTE MATERIAL. THE FSE CLEANED THE OPENING AND A TUBE CLAMP WAS INSTALLED ON THE FITTING AT THE SIDEWALL. THE ISE WAS PRIMED AND NO FURTHER LEAKING WAS OBSERVED. ISE QUALITY CONTROL (QC) AND SYSTEM PERFORMANCE WAS VERIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING AN UNCONTAINED IONIZED SELECTIVE ELECTRODE (ISE) DRAIN LEAK IN THE SYNCHRON CX5 PRO CLINICAL SYSTEM. APPROXIMATELY 10 MLS OF FLUID HAS LEAKED UNDER THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193707 SYNCHRON® CX5 PRO CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER CX5 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1