BEUDAMED
    FDA Recall Terminated

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

    Recall: Z-0120-2021 · Initiated June 30, 2020

    Recall

    Recall Number
    Z-0120-2021
    Event Number
    86062
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 30, 2020
    Posted
    October 22, 2020
    Terminated
    April 29, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

    Reason

    Baxter is updating the device IFU for safety communication regarding cleaning practices.

    Action

    A Safety Alert communication was sent to affected customers on 04/01/2020 via USPS First Class Mail. A follow-up Urgent Device Correction communication was sent to all affected customers on 8/28/2020 via USPS first class mail. The customer communications reiterate instructions for use listed in the Operator's Manual. Baxter is asking customers to: 1) Operators may continue to safely use the infusion pumps while following the instructions for cleaning provided in the Operator's Manual. An electronic copy of the Operator's Manual can be accessed at https://service.baxter.com. In addition, a full list of approved cleaning agents can be accessed at www.spectrumIQ.com/resources.html. 2) Inspect all pumps at their facility to assess the electrical pins on the pump rear case and the battery electrical contacts for residue buildup or corrosion. If corrosion or residue buildup is identified, please contact Baxter to service the device. 3) Baxter will be updating the Instructions for Use to recommend a routine inspection process for the electrical pins on the pump rear case and the battery electrical contacts. Once the updated Instructions for Use are made available, Baxter will issue a written notification to inform customers of the availability of the updated IFU. The updated IFU may be accessed online at the Baxter Global Technical E Service Center at URL: https://service.baxter.com. 4) Clinicians should ensure backup devices are readily available when infusing critical medications where interruptions could cause serious injury or death. 5) To maintain the battery properly, please ensure the pumps are plugged into AC power when possible to prevent battery depletion. 6) Complete the enclosed customer reply form and return it to Baxter by email. On 9/22/2021, the firm issued an Urgent Device Correction letter dated 9/22/2021 in follow-up to their communication of the 4/1/2020 safety alert and 8/28/2020 Urgent Device Correction. This was issued via first class USPS ma

    Distribution

    Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

    Quantity

    9352 units