BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 3151182 · Received June 7, 2013

    Report

    Report Number
    1061932-2013-01094
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    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 TO EVALUATE THE INSTRUMENT. THE FSE HAD OBSERVED THAT THE SOURCE OF THE LEAK WAS A HOLE IN THE TUBING AT PINCH VALVE (PV) 44. THE FSE REPLACED THE AFFECTED TUBING AND NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. FAILURE MODE IS RELATED TO A HOLE IN THE TUBING AT THE PV44. 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 A LEAK WAS OBSERVED ON THE COULTER LH 500 HEMATOLOGY INSTRUMENT WHILE RUNNING QUALITY CONTROL (QC). THE VOLUME OF THE LEAK WAS LESS THAN 20ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, PROTECTIVE EYEWEAR, AND A LABORATORY COAT AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT 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 ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252089 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1