BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 3212144 · Received July 8, 2013

    Report

    Report Number
    2050012-2013-00432
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND INSPECTED THE CAP PIERCER FOR OBSTRUCTING DEBRIS BUT NONE WAS FOUND. THE FSE OBSERVED THAT THE CAP PIERCER WASTE VALVE WAS SLOW TO EMPTY WASTE WHEN THE CAP PIERCER WAS ENGAGED AND PROCEEDED TO REPLACE THE WASTE VALVE. NO FURTHER LEAKS WERE OBSERVED AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE CAP PIERCER WASTE 3 WAY SOLENOID VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING AN OVERFLOW FROM THE CAP PIERCER OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WHICH APPEARED TO BE WATER WHILE PIERCING SAMPLE TUBE CAPS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYEWEAR AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311513 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1