BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2900628 · Received January 8, 2013

    Report

    Report Number
    1061932-2013-00018
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 9, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED THAT THE SOURCE OF THE LEAK WAS A DISCONNECTED TUBING AT THE SHEATH RESTRICTOR. THE FSE REATTACHED THE TUBING NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. FAILURE MODE: THE CAUSE OF THE LEAK WAS A DISCONNECTED TUBING AT THE SHEATH RESTRICTOR. PER LABELING, 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 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 INC. (BEC) REPORTING THAT WHILE BEGINNING STARTUP A LEAK WAS OBSERVED IN THE BACK OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS APPROXIMATELY 500 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY FLAGS OR ERROR MESSAGES AS A RESULT OF THIS EVENT. THE CUSTOMER OBSERVED THE LEAK WHEN STARTING UP THE INSTRUMENT AT THE BEGINNING OF THE MORNING SHIFT. THE CUSTOMER WAS WEARING PERSONAL PROPER EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO SAMPLES WERE AFFECTED OR REPORTED AS A RESULT OF THE LEAK. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9746 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1