BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH750

    MDR report key: 2424838 · Received January 23, 2012

    Report

    Report Number
    1061932-2012-00198
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 2, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLOODY LEAK AT THE BELLOWS OF THE BECKMAN COULTER LH750 INSTRUMENT. THERE WERE NO PATIENT SAMPLES OR RESULTS AFFECTED BY THE LEAK. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, PROTECTIVE EYE WEAR AND GLOVES AT THE TIME OF THE INCIDENT. THE MSDS WAS NOT REVIEWED. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE NEEDLE BELLOWS WERE NOT DRAINING. THE FSE REPLACED THE CHECK VALVE BETWEEN VL13 AND THE NEEDLE. THE REPAIRS WERE VERIFIED PER THE ESTABLISHED PROCEDURES. ROOT CAUSE OF THE LEAK IS ATTRIBUTED TO THE NEEDLE BELLOWS NOT DRAINING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LH750 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH750

    Patients

    Seq Age Sex Outcome Treatment
    1