BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171228 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00752
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS USING 5ML HEMOGUARD TUBES. 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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZERS. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) VERIFIED INSTRUMENT OPERATIONS AND INSTRUCTED THE TECH ON DUTY TO CAUTION THE PHLEBOTOMY STAFF TO AVOID PRESSURIZING THE SAMPLE TUBES WHEN USING A SYRINGE TO TRANSFER PATIENT SAMPLES INTO THE HEMOGUARD TUBES. ROOT CAUSE FOR THE SAMPLE CAPS POPPING OFF IS UNKNOWN, BUT MAY BE ATTRIBUTED TO THE SAMPLE TUBES BEING IMPROPERLY COLLECTED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL BIOHAZARD WHEN THE CAPS OF THREE BLOOD SAMPLE TUBES POPPED OFF DURING INSTRUMENT SAMPLE CYCLING WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CONTENTS OF THE BLOOD SAMPLE TUBES WERE SPILLED WHEN THIS OCCURRED. THE OPERATOR WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AND THERE WAS NO EXPOSURE TO BLOOD. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. 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 UNK