BEUDAMED
    FDA Enforcement Class I Ongoing

    CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

    Recall: Z-1359-2020 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1359-2020
    Event ID
    84579
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2020
    Initiation Date
    February 4, 2020
    Classification Date
    March 5, 2020
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

    Reason

    1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders

    Code Info

    Model 8000, software versions 9.5 and prior; Model 8015, software versions 12.1.0, and 9.33 and prior

    Distribution

    Worldwide Distribution: (U.S. Nationwide) to states of: CO, SC, NY, CA, LA, TX, AK, ID, VA, DE, FL, PA, KY, KS, TN, WA, MS, IL, GA, AR, NC, NV, NE, OR, RI, WI, HI, GU, PR, MA, IA, CT, MI, AZ, ME, MT, IN, OH, WV, WY, MN, AL, NH, OK, DC, NJ, MO, SD, UT, NM, MD, VT, MP, ND, AS; and countries of: Canada, Australia, New Zealand, the Middle East, South Africa, Taiwan, Southeast Asia and the European Union.

    Quantity

    870070