BEUDAMED
    FDA Recall Open, Classified

    CADD Solis HSPCA Pump

    Recall: Z-1662-2025 · Initiated April 10, 2025

    Recall

    Recall Number
    Z-1662-2025
    Event Number
    96628
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    3012307300
    Product Code
    MEA
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 10, 2025
    Posted
    May 7, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CADD Solis HSPCA Pump

    Reason

    Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

    Action

    Firm began notifying customers on April 10, 2025 via letters titled "Urgent Medical Device Correction." Customers were instructed to validate any wireless network changes or updates to hospital network settings with the pump/communication module to ensure compatibility of the wireless connection before deploying network setting changes or updates to the production environment. If the alarm recurs or is unable to be cleared by power cycling the pump, the customer should revert to prior compatible network settings or turn off the wireless function of the communication module. The firm will also address the issue with a software update. Smiths Medical will contact customers to schedule implementation of the software update once it is available.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    US: 83,833 items ; OUS: 71,843 items