BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 3152748 · Received June 8, 2013

    Report

    Report Number
    2050012-2013-00367
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED AN OBSTRUCTION IN THE COLLAR WASH VALVE. THE FSE COULD NOT DETERMINE THE NATURE OR ORIGIN OF THE OBSTRUCTION BUT REMOVED THE OBSTRUCTION TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO AN OBSTRUCTED COLLAR WASH. RESULTS: OBSTRUCTION IN THE COLLAR WASH VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCOVERING LIQUID IN THE DRIP TRAY BELOW REAGENT PROBE B OF THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT APPROXIMATELY 10 ML OF FLUID LEAKED AND THE REAGENT SYRINGE WAS A LITTLE LOOSE BUT THE PROBE CONTINUED TO LEAK AFTER TIGHTENING THE SYRINGE. IT IS UNKNOWN OF WHAT PERSONAL PROTECTIVE EQUIPMENT WAS WORN BY THE CUSTOMER AT THE TIME OF THE EVENT BUT NO INJURY OR EXPOSURE WAS REPORTED. THE CUSTOMER HAS A RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. 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
    254465 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1