BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2544011 · Received April 20, 2012

    Report

    Report Number
    1061932-2012-01380
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    March 27, 2012
    Report Date
    March 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    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

    A FIELD SERVICE ENGINEER (FSE) FOUND TUBING FROM VALVE (VL-43) WAS LEAKING AND REPLACED ALL CENTRAL PANEL TUBING. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE CAUSE OF THE LEAK IS ATTRIBUTED TO TUBING AT VL-43. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) REPORTING THAT APPROXIMATELY 30ML OF BLUE FLUID DRIPPED FROM UNDER THE COULTER LH 500 HEMATOLOGY ANALYZER. THE FLUID WAS NOT CONTAINED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF A LAB COAT AND GLOVES, WITHOUT FACE PROTECTION. THE CUSTOMER REPORTED THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES SUCH AS THE EYE, NOSE OR MOUTH. MEDICAL ATTENTION WAS NOT SOUGHT. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WERE NO PATIENT RESULTS AFFECTED AND THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LAB. NO DEATH OR INJURY IS ASSOCIATED WITH THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1