BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY INSTRUMENT

    MDR report key: 3253255 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01628
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE STATED THAT THE CUSTOMER REPLACED THE TUBING AT PV49 PRIOR TO HIS ARRIVAL. PV49 IN ITS NORMAL STATE PROVIDES AN OPEN PATH FOR VACUUM AND DILUENT TO PUMP PM8. THE INSTRUMENT GENERATED PRESSURE AND VACUUM ERRORS AFTER THE TUBING WAS REPLACED. THE FSE ALSO FOUND THE TEETH ON VALVE VL49 WERE BROKEN. THE FSE REPLACED THE BROKEN TEETH AND ALL TUBING TO PV49 RESOLVING THE LEAK ALONG WITH THE PRESSURE AND VACUUM ERRORS. FAILURE MODE IS RELATED TO A LEAK AT THE PV49. 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. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK OF AN UNKNOWN VOLUME COMING FROM THE RIGHT SIDE OF THE COULTER LH 500 HEMATOLOGY INSTRUMENT. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR 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. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353904 COULTER® LH 500 HEMATOLOGY INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1