BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2880636 · Received December 19, 2012

    Report

    Report Number
    1061932-2012-02890
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED WEAK PROBE-WIPE AIR CYLINDER, DEFECTIVE WHITE BLOOD CELL (WBC) PUMP, AND FAULTY BLOOD SAMPLING VALVE (BSV) ACTUATOR. THE FSE REPLACED THE PROBE-WIPE CYLINDER AND BSV ACTUATOR TO RESOLVE THE FLUID LEAK ISSUE. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND NOTED RESULTS CONFORMED TO THE PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN ONE MILLILITER OF FLUID LEAKED WITHIN, ON THE LOWER FRONT COVER OF THE INSTRUMENT, FROM THE SECONDARY MODE INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. 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 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 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1