BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 2230308 · Received September 1, 2011

    Report

    Report Number
    1061932-2011-01333
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2011 FOR THIS EVENT AND INDICATED THAT THE BATH WAS OVERFLOWING DUE TO A CRIMPED WASTE LINE. THE FSE REPLACED THE BLOODY VACUUM ISOLATION CHAMBER (VIC) AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. ROOT CAUSE FOR THE LEAK IS A CRIMPED WASTE LINE THAT DID NOT ALLOW THE WBC AND RBC BATHS TO DRAIN PROPERLY. 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. (BCI) REPORTING A POOL OF BIOHAZARD FLUID UNDERNEATH THE COULTER AC*T DIFF 2 ANALYZER. WHILE CYCLING PATIENT SAMPLES A VACUUM FAILURE WAS DISPLAYED. THE CUSTOMER INSPECTED THE INSTRUMENT AND FOUND THE RED BLOOD COUNT (RBC) AND WHITE BLOOD COUNT (WBC) BATHS HAD OVERFLOWED. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF ANY PATIENT RESULTS BEING AFFECTED BY THIS INCIDENT. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1