BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2213568 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04535
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CHECKED THE PROBE TUBING, THE SYRINGE, AND THE TUBING TO THE VALVE. THE CUSTOMER STOPPED, HOMED THE SYSTEM, AND RAN QC. THE DRIPPING FROM THE PROBE CONTINUED. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE FOUND THE REAGENT PROBE WASH COLLAR LEAKING, AND REAGENT A VACUUM VALVE WAS WORN OUT. THE FSE REPLACED THE VACUUM VALVE. THE FSE VERIFIED THE PROBES WERE CLEAR, AND REALIGNED WASH STATION. THE FSE PERFORMED CUVETTE WASH WITH NO ERRORS OR LEAKING OBSERVED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE CARTRIDGE CHEMISTRY SAMPLE PROBE ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS DRIPPING FLUID. NO PATIENT SAMPLE WAS RUN ON THE INSTRUMENT ON THE DAY OF THE EVENT. THE CUSTOMER WAS WEARING PPE. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1