BEUDAMED
    FDA Recall Open, Classified

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

    Recall: Z-0714-2021 · Initiated November 23, 2020

    Recall

    Recall Number
    Z-0714-2021
    Event Number
    86758
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 23, 2020
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.

    Reason

    There is a potential software error during programming.

    Action

    A Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.

    Quantity

    140,006 devices