BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC.T DIFF ANALYZER

    MDR report key: 2811451 · Received October 31, 2012

    Report

    Report Number
    1061932-2012-02602
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND DISCOVERED THE RINSE BLOCK WAS LEAKING. UPON INSPECTION, THE FSE FOUND THAT THE TUBING THROUGH PINCH VALVE LV8, WHICH CONTROLS THE PROBE WASH DRAIN, WAS CLOGGED. THE FSE FLUSHED THE PROBE WASH DRAIN TUBING AND THE LEAK ISSUE WAS RESOLVED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THE FAILURE MODE OF THE EVENT WAS THE CLOGGED TUBING THROUGH LV8. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT APPROXIMATELY 10 ML LEAK AT THE PROBE OF THE ACT DIFF INSTRUMENT, WHICH WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FLUID ASSOCIATED WITH THIS EVENT ARE DILUENT, BLOOD AND CLENZ. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES ONLY. PATIENT RESULTS WERE NOT IMPACTED BY THIS EVENT. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY HAS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1