BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 1914645 · Received December 3, 2010

    Report

    Report Number
    1061932-2010-00245
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT IS CURRENTLY PERFORMING WITH ACCEPTABLE LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE CORRESPONDING TUBING AND THE LYSE RESTRICTOR TUBING, WHICH WAS THE ATTRIBUTING FACTOR TO THE ROOT CAUSE OF THIS EVENT. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE OPERATOR DISCOVERED A LEAK UNDERNEATH THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS ISOLATED TO THE CORRESPONDING TUBING, WHICH CARRIES THE VACUUM FOR THE PROBE AND NEEDLE DRAIN, AS WELL AS THE LYSE RESTRICTOR TUBING. LYSE REAGENT AND BLOOD PRODUCTS ARE CARRIED THROUGH THIS TUBING. THERE WAS NO EXPOSURE TO SKIN, EYES, OPEN LESIONS OR MUCOUS MEMBRANES. NO MEDICAL TREATMENT WAS SOUGHT BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1