BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2251214 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01375
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    January 13, 2009
    Report Date
    January 14, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LAB ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LAB ANALYZER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. BASED ON AVAILABLE INFO, THE ROOT CAUSE MAYBE ATTRIBUTED TO OPERATOR REAGENT HANDLING AND NOT WEARING THE PROPER PERSONAL PROTECTIVE EQUIPMENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE OPERATOR SPILLED SOME LH SERIES REAGENT ON THEIR LEG WHILE CHANGING THE REAGENT CUBE ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUBE WAS UNCAPPED AND WHEN LIFTED IT TILTED AND SPILLED. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF ONLY GLOVES AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE OPERATOR FLUSHED THE LEG WITH WATER AS DIRECTED THE MSDS SHEET. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT AS A RESULT OF THIS EVENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE LAB'S EXPOSURE CONTROL OR RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO DEATH, INJURY OR CHANGE TO PT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LH SERIES DILUENT