BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2504317 · Received March 26, 2012

    Report

    Report Number
    1061932-2012-00960
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A BLOOD AND DILUENT LEAK OF APPROXIMATELY 5 TO 10 MILLILITERS FROM THE SAMPLE PROBE OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES. CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID, AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS, AND NO ONE WAS SPLASHED OR SPRAYED. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR ASSOCIATED WITH THIS COMPLAINT. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE SOURCE OF THE LEAK WAS THE DISCONNECTED TUBING AT QUICK DISCONNECT (QD) 421F. QD421F IS THE PATH FOR THE PROBE WASTE. THE FSE INSERTED THE TUBING OVER THE FITTING OF QD421F, AND CLEANED THE SAMPLING PROBE AND THE AREA BENEATH THE SAMPLING PROBE. THERE WAS NO FURTHER EVIDENCE OF LEAKING. THE FSE THEN VERIFIED INSTRUMENT PERFORMANCE TO ENSURE THAT THE SERVICES PERFORMED EFFECTIVELY RESOLVED THE INSTRUMENT ISSUE. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THIS EVENT. THE ROOT CAUSE OF THE LEAK WAS THE DISCONNECTED TUBING AT QD421F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800

    Patients

    Seq Age Sex Outcome Treatment
    1