BEUDAMED
    FDA Recall Open, Classified

    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

    Recall: Z-2103-2023 · Initiated June 15, 2023

    Recall

    Recall Number
    Z-2103-2023
    Event Number
    92562
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 15, 2023
    Posted
    July 13, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    SIGMA Spectrum Infusion Pump, Product Code 35700BAX2

    Reason

    A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

    Action

    Customers were contacted via phone and email beginning on June 2, 2023. An Urgent Medical Device communication was sent to all affected customers on June 15, 2023, via U.S.P.S., first class mail. The notice explained the problem, the risk involved, and requested the following: "Actions to be taken by Customers: 1. Operators may continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions, or the infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator s Manual. An electronic copy of the Operator s Manual can be accessed at https://service.baxter.com/tsportal/. Please note that false upstream occlusion alarms can occur at a higher rate until the software reversion is completed. If you are unable to resolve an upstream occlusion alarm, unload and reload the set. 2. A Baxter representative will contact your facility to determine the correction plan and schedule the software reversion. The representative will work with you to determine a list of affected serial numbers at your facility. Please note you will be receiving this software reversion from Baxter at no charge." "Further information and support: If you have additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-356-3454 (choose option 3) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."

    Distribution

    US Nationwide distribution.

    Quantity

    3306 units