BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2895079 · Received January 3, 2013

    Report

    Report Number
    1061932-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE PROBE WASH COLLAR VACUUM SUPPLY WAS INTERMITTENT AND WEAK. THE FSE REPLACED THE PROBE WASH COLLAR VACUUM PATH SOLENOID VALVE VL341 AND FLUSHED VACUUM PATHWAY TO RESOLVE THE ISSUE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN ONE MILLILITER OF DILUENT AND BLOOD FLUID LEAKED WITHIN THE INSTRUMENT FROM THE PROBE RINSE BLOCK INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND FACE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS A BIOHAZARD SPILL CLEANUP PROCEDURE AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3289 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1