BEUDAMED
    FDA Recall Terminated

    Dose IQ Safety Software used with Spectrum IQ Infusion Pump

    Recall: Z-2165-2021 · Initiated July 7, 2021

    Recall

    Recall Number
    Z-2165-2021
    Event Number
    88246
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 7, 2021
    Posted
    August 11, 2021
    Terminated
    June 20, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Dose IQ Safety Software used with Spectrum IQ Infusion Pump

    Reason

    Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum IQ pump.

    Action

    The firm issued an Urgent Medical Device Correction notice by letter on July 7, 2021. The letter explained the issue and provided a temporary workaround which can be implemented until the new software tool is ready for distribution.

    Distribution

    US Nationwide Distribution.

    Quantity

    61 units