BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2902500 · Received January 8, 2013

    Report

    Report Number
    1061932-2013-00019
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 AND CONFIRMED THE LEAK FROM THE PINCH VALVE (PV43). THE I-BEAM TUBING IN THE NORMALLY CLOSED POSITION FAILED DUE TO FATIGUE. THE FSE REPLACED THE TUBING, RESOLVING THE LEAK, AND THE INSTRUMENT WAS VERIFIED. FAILURE MODE IS RELATED TO I-BEAM TUBING THROUGH PV43. PER THE OPERATOR'S GUIDE / IFU: WARNINGS AND PRECAUTIONS: 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT LESS THAN 10 ML OF FLUID DESCRIBED AS A COMBINATION OF CLENZ, DILUENT AND BLOOD HAD LEAKED FROM PINCH VALVE (PV43) OF THE COULTER LH 500 INSTRUMENT. THE LEAK WAS NOT CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, GLASSES AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8709 COULTER® LH 500 INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1