BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LH SLIDE STAINER

    MDR report key: 2182857 · Received July 28, 2011

    Report

    Report Number
    1061932-2011-00963
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GIF
    PMA / PMN Number
    CL. 1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING ACTIVITIES PERFORMED. EYE SPLASH. PPE NOT WORN AT TIME OF EVENT. 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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. THE CONTENTS OF THE REAGENT CONTAINERS AND ITS ASSOCIATED TUBING CONTAIN MATERIAL WHICH CAN STAIN SKIN AND MUST BE HANDLED WITH CARE. THE PERISTALTIC TUBING MAY CONTAIN RESIDUAL STAIN AND MUST BE HANDLED WITH CARE. AVOID SKIN CONTACT. CLEAN UP SPILLS IMMEDIATELY IN ACCORDANCE WITH LOCAL REGULATIONS AND ACCEPTABLE LABORATORY PROCEDURES. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT AN OPERATOR RECEIVED AN EYE SPLASH WHILE TROUBLESHOOTING TO REPLACE TUBING THAT HAD BACKED UP WITH SEDIMENT TO THE WRIGHT STAIN ON THEIR LH SLIDE STAINER. THE OPERATOR ATTEMPTED TO TROUBLESHOOT THE INSTRUMENT WITHOUT THE AID OF A BECKMAN COULTER TECHNICAL SPECIALIST AFTER OBSERVING THAT THE BATHS WERE NOT DRAINING OR FILLING PROPERLY. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) TO PROTECT HIS EYES AT THE TIME OF THE EVENT. THE OPERATOR WAS WEARING CONTACT LENSES AT THE TIME OF THE EVENT. PER SECTION SIX OF THE CLEANING AND REPLACEMENT PROCEDURE OF THE OPERATOR'S GUIDE (BECKMAN COULTER PART NUMBER 4277300DB), OPERATORS ARE ADVISED TO WEAR PPE WHILE PERFORMING TROUBLESHOOTING ACTIVITIES. THE OPERATOR FLUSHED HIS EYES WITH WATER AT AN EYE WASH STATION AND THEN SOUGHT MEDICAL ATTENTION. THE OPTOMETRIST DETERMINED THAT THERE WAS NO SERIOUS INJURY TO THE EYE AND THAT THERE SHOULD BE NO PERMANENT DAMAGE. IT IS UNKNOWN IF THE OPERATOR HAD REVIEWED THE MATERIAL SAFETY DATA SHEET (MSDS). THE FACILITY DOES HAVE AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE. THE OPERATOR, WHILE TROUBLESHOOTING, HAD REPLACED THE WASTE FILTER, TUBING, AND PERISTALTIC PUMP TO BATH TWO. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE VERIFIED THE REPAIRS MADE BY THE OPERATOR PER ESTABLISHED PROCEDURES. THERE WAS NO IMPACT TO PATIENT SAMPLE RESULTS OR PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention