BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3093305 · Received May 6, 2013

    Report

    Report Number
    1061932-2013-00803
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED FLUID LEAKED AROUND THE DIFFERENTIAL MIXING CHAMBER. THE FSE OBSERVED THE SHEATH FLOW RESTRICTOR TUBING WAS LEAKING AND REPLACED THE TUBING TO RESOLVE THE ISSUE. THE FSE CLEANED THE FLUID SPILL AREA AND PERFORMED SYSTEM VERIFICATION INCLUDING STARTUP, LATRON CONTROL, CONTROLS, AND REPRODUCIBILITY CHECK; ALL RESULTS WERE WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN FIFTY (50) MILLILITERS OF CLEAR FLUID LEAKED OUTSIDE THE INSTRUMENT AROUND THE DIFFERENTIAL CHAMBER AND FLOWCELL OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE 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 AS SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196820 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1