BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 3093021 · Received May 3, 2013

    Report

    Report Number
    1061932-2013-00798
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE FOUND THAT THE RINSE BLOCK WAS BAD AND NEEDED REPLACING. THE FSE REPLACED THE TUBINGS THAT WERE WORN FOR PINCH VALVE (PV) 35, 40, 42 AND 49 THAT ARE ASSOCIATED WITH THE RINSE BLOCK AND VERIFIED PROBE ALIGNMENT TO RINSE BLOCK. THE RINSE BLOCK WAS SENT TO THE CUSTOMER AND THE FSE WALKED THE CUSTOMER THROUGH INSTALLING THE NEW RINSE BLOCK BY PHONE. CUSTOMER STATED THAT THERE NO MORE DRIPPING AFTER THE RINSE BLOCK WAS INSTALLED AND THE UNIT IS OPERATIONAL. PER LABELING, BECKMAN COULTER 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE MANUAL PROBE WAS DRIPPING ON THE COULTER LH 500 HEMATOLOGY INSTRUMENT DURING STARTUP AND SHUT DOWN. THE VOLUME OF THE LEAK WAS SEVERAL DROPS AND WAS CONTAINED WITHIN THE UNIT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO DISCREPANT PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194500 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1