BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3081466 · Received April 29, 2013

    Report

    Report Number
    1061932-2013-00637
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE PERFORMED BLOOD SAMPLING VALVE (BSV) ROTATION AND NOTED NO HESITATION OR BINDING. THE FSE THEN PERFORMED MANUAL PROBE WASH AND NOTED CORRECT VACUUM AND RINSING. THE FSE FOUND A LEAK FROM LOOSE TUBING AT THE FRONT OF THE BLOOD DETECTOR AT WIRE MARKER 3 (WM3) ON THE BSV. THE FSE REPLACED THE TUBING RESOLVING THE LEAK AND PERFORMED MULTIPLE SYSTEM TESTS TO VERIFY FLUIDICS. THE CAUSE OF THE LEAK WAS THE LOOSE TUBING AT WM3 ON THE BSV. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT 0.5 ML OF BLOODY FLUID HAD LEAKED FROM THE BLOOD SAMPLING VALVE (BSV) ONTO THE COUNTER DURING A STARTUP AND WHEN THE CUSTOMER WAS RUNNING 5C CELL CONTROLS ON THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185676 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1