BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3031776 · Received April 2, 2013

    Report

    Report Number
    2050012-2013-00206
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE SYRINGE HOWEVER A LEAK WAS STILL OBSERVED UNDER REAGENT PROBE A. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND FOUND THAT THE SOLENOID VALVE WAS NOT PROVIDING ENOUGH VACUUM TO THE WASH COLLAR TO PREVENT FLUID FROM ESCAPING THROUGH THE BOTTOM PORT. THE FSE REPLACED THE VALVE WHICH RESOLVED THE ISSUE. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE SOLENOID VALVE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A DRIPS OF FLUID UNDER THE WASH COLLAR OF REAGENT PROBE A OF A UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING A LAB COAT, GLOVES AND EYEWEAR AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134558 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1