BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171231 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00788
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 15, 2008
    Report Date
    March 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER PRODUCT 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 LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. ON (B)(6) 2008, THE FIELD SERVICE ENGINEER EVALUATED THE ANALYZER AND DETERMINED THAT THE WASTE SENSOR WAS WORKING CORRECTLY. THE OVERFLOW WAS NOT LIQUID, WAS MANY BUBBLES AFTER ADDING BLEACH TO THE WASTE TANK. ROOT CAUSE OF THE OVERFLOW IS UNKNOWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN THE WASTE CONTAINER OF THE COULTER LH 750 HEMATOLOGY ANALYZER OVERFLOWS AFTER BLEACH IS ADDED. THE CUSTOMER STATED THAT THERE MAY BE A POTENTIAL FOR EXPOSURE FROM WASTE AND REQUESTED THE STANDARD WASTE PICKUP TUBE BE EXTENDED 3.5 CM. OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN SKIN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT ON OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    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 NA