BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2802221 · Received October 23, 2012

    Report

    Report Number
    1061932-2012-02606
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED TUBING ((B)(4)), WHICH SUPPLIES RINSE FROM BACKWASH MANIFOLD, DISCONNECTED FROM THE BLOOD SAMPLING VALVE (BSV) CENTER SECTION. THE FSE CUT THE BACK END OF TUBING AND RECONNECTED IT TO THE BSV FITTING. THE FSE REPLACED THE DAMAGED NEEDLE CARTRIDGE AND COMPLETED INSTRUMENT VERIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER THE ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. CARTRIDGE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY FIFTY (50) MILLILITERS OF BLUE FLUID LEAKED FROM THE INSTRUMENT AND ONTO THE COUNTERTOP DURING SYSTEM STARTUP INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT DURING THE EVENT. THE CUSTOMER 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 AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN 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
    1 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1