BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2840513 · Received November 20, 2012

    Report

    Report Number
    1061932-2012-02689
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 27, 2012
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE CUSTOMER BY PHONE TO TROUBLESHOOT THE SOURCE OF THE LEAK. THE CUSTOMER FOUND THE LEAK AT PV41 IN THE I BEAM TUBING. THE PV41 CARRIES THE SAMPLE FLUID FROM THE SHEAR VALVE TO THE MIXING CHAMBER ON THE LH780 INSTRUMENT. THE CUSTOMER REPLACED THE I BEAM TUBING AT PV41 TO RESOLVE THE ISSUE. 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 EVENT WAS LEAK IN I BEAM TUBING AT PV41. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED A LEAK FROM IN FRONT OF THE COULTER LH 780 HEMATOLOGY INSTRUMENT. THE VOLUME WAS REPORTED AS 30 ML AND THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING A LAB COAT AND GLOVES. NO ONE WAS SPLASHED, SPRAYED OR INJURED. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THE MSDS WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THERE WAS NO DEATH, INJURY OR AN EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1