BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDE STAINER

    MDR report key: 2171245 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00778
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    KPA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER PRODUCT LABELING, BECKMAN COULTER INC URGES CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS, SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. ON 02/27/2008, THE FIELD SERVICE ENGINEER (FSE) INSPECTED AND REPLACED THE FITTING ON THE DRAIN TUBING IN BATH #2. THE FSE CHECKED THE LINE FOR BLOCKAGE. ROOT CAUSE WAS THE FITTING ON THE DRAIN TUBING IN BATH #2. REPLACING THE FITTING WAS THE CORRECTION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL CHEMICAL HAZARD WHEN TWO LABORATORY PERSONNEL WERE SPRAYED WITH WRIGHT STAIN REAGENT FROM THE COULTER LH 750 SLIDE STAINER. THE INCIDENT OCCURRED WHEN THE BATH #2 DRAIN LINE TUBING BECAME DISCONNECTED FROM THE FITTING ON THE COULTER LH 750 SLIDE STAINER. THE TWO LABORATORY PERSONNEL WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) OF LAB COATS, GLASSES AND GLOVES. THE WRIGHT STAIN REAGENT WAS SPRAYED ONTO CLOTHING AND PPE. SKIN, MUCOUS MEMBRANES OR OPEN LESIONS WERE NOT EXPOSED TO THE REAGENT. MEDICAL TREATMENT WAS NOT SOUGHT FOR EITHER LABORATORY PERSONNEL. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 SLIDE STAINER KPA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK