BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2103127 · Received May 25, 2011

    Report

    Report Number
    1061932-2011-00486
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT ON (B)(4) 2011. PER FSE, THE CLENZ LEAK WAS DUE TO A CUT IN THE TUBING THROUGH (VL45) LOCATED INSIDE THE ANALYZER'S CENTER MAIN DILUTER PANEL. FSE REPLACED THE TUBING AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE FOR THE LEAK WAS ASSOCIATED WITH A CUT IN THE TUBING THROUGH (VL45) LOCATED IN THE MAIN PANEL. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT A LEAK (CLENZ) IN THE COULTER LH 500 HEMATOLOGY ANALYZER. USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND GOGGLES AT TIME OF INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1