BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2032817 · Received March 29, 2011

    Report

    Report Number
    2050012-2011-00897
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN WAS HELPING OTHER TECHNICIANS TO OPEN THE NO FOAM BOTTLE WITHOUT REALIZING THAT THE SYSTEM HAS TO BE DEPRESSURIZED PRIOR TO OPENING. THE CUSTOMER FAILED TO FOLLOW THE INSTRUCTIONS FOR USE. THE TECHNICIAN FELT THE RELEASED PRESSURE WITH THE HISSING SOUND AND THE FUME. THE TECHNICIAN WAS WEARING EYE GLASSES, GLOVES AND LAB COAT, AND NO FOAM DID NOT SPLASH INTO THE TECHNICIAN'S EYES. THE TECHNICIAN WAS EVALUATED AT THE FACILITY'S HEALTH CENTER FOR BEING EXPOSED TO THE FUME WHEN THE NO FOAM BOTTLE WAS OPENED. THE TECHNICIAN CONFIRMED THAT SHE WAS OKAY AND NO INJURY WAS REPORTED. THE CUSTOMER STATED THE SYSTEM WAS RESUMED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NO FOAM REAGENT SPRAY FROM UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES, AND NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1