BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    MDR report key: 3290935 · Received August 15, 2013

    Report

    Report Number
    1061932-2013-01766
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE TUBING THROUGH PINCH VALVE LV13 WAS PINCHED. THE FSE REPLACED THE TUBING AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. 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 A LEAK AT THE BATHS OF THE COULTER AC-T DIFFERENTIAL HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS ABOUT 100 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES 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. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394549 COULTER AC*T DIFF HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1