BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER ANALYZER

    MDR report key: 2192390 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01117
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT. THE FSE OBSERVED A LEAK CONSISTING OF DILUENT AND A SMALL AMOUNT OF BLOOD IN THE SECOND PORT VACUUM LINE OF THE RINSE BLOCK. THE FSE ALSO DISCOVERED DRIED UP CLENZ AROUND THE WHITE BLOOD COUNT (WBC) BATH APERTURE HOUSING WHICH THE FSE CLEANED. THE FSE DETERMINED THAT THE ROOT CAUSE OF THE LEAK WAS DUE TO A TRAPPED SMALL QUANTITY OF PARTICULATE MATTER IN THE RINSE BLOCK VACUUM LINE. THE FSE REPLACED THE VC6 (VACUUM CHAMBER THAT DISTRIBUTES VACUUM IN THE DILUTER) TO IMPROVE THE VACUUM DISTRIBUTION. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. 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. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING A LEAK IN THE COULTER HMX AUTOLOADER ANALYZER INSTRUMENT'S WASH TRUCK. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE INCIDENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE WAS SPLASHED, SPRAYED, OR INJURED. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX AUTOLOADER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. HMX AL 115V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1