BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH¿ 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2180045 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-00962
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS MEDWATCH REPORT IS RELATED TO TWO OTHER MEDWATCH REPORTS PERTAINING TO THE SAME EVENT BUT OCCURRING ON SEPARATE DAYS: MDR REPORT NUMBER: 1061932-2011-00965. MDR REPORT NUMBER: 1061932-2011-00966.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT A PLUGGED NRBC CHAMBER THAT OVERFLOWED A PATIENT SAMPLE ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AT THE TIME OF THE EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT THE SAMPLE FROM THE NRBC MIXING CHAMBER OVERFLOWED WHEN THE CHAMBER BECAME OBSTRUCTED WITH RUBBER DEBRIS FROM THE SPECIMEN TUBES. THIS PARTICULAR ISSUE OCCURRED ON THREE SEPARATE DATES: (B)(6) 2011. THIS MEDWATCH REPORT CORRESPONDS TO THE EVENT DATE OF (B)(6) 2011. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE - GOWN AND GLOVES) WHEN THE LEAK WAS DISCOVERED. THERE WAS NO INJURY OR EXPOSURE TO THE OPERATOR. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. IT IS UNKNOWN IF THE CUSTOMER REFERRED TO THE MATERIAL SAFETY DATA SHEET (MSDS). THE CUSTOMER DOES HAVE AN EXPOSURE CONTROL PLAN IN PLACE AT THEIR FACILITY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REMOVED THE PROBE AND OBSERVED THAT IT WAS WORN (AT APPROXIMATELY 5000 CYCLES). THE FSE REPLACED THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH¿ 800 COULTER® CELLULAR ANALYSIS SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1