Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

• • Ongoing Z-2096-2025 FDA Class I ·initiated 20 Jun 2025 ·on shared 510(k) K230022

  Certain Spectrum infusion pumps may have an incorrect version of software.

• • Ongoing Z-0776-2025 FDA Class II ·initiated 19 Nov 2024

  Devices were identified as released after repair without full testing being performed, which includes flow testing.

• • Ongoing Z-2581-2024 FDA Class II ·initiated 17 Jul 2024

  The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.

• • Ongoing Z-2530-2024 FDA Class II ·initiated 14 Jun 2024

  Improperly performed testing prior to release

• • Ongoing Z-2103-2023 FDA Class I ·initiated 15 Jun 2023

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K230022 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Baxter Healthcare Corporation →

• What is the Baxter SIGMA Spectrum Infusion Pump used for?

  The Baxter SIGMA Spectrum Infusion Pump is a software-controlled device designed to deliver fluids to patients in general hospital settings. It features safety capabilities like a configurable dose error reduction system (DERS), single step titration, flow check at run, and secondary container infusion check to help prevent medication errors.

• How is the Baxter SIGMA Spectrum Infusion Pump supplied?

  The Baxter SIGMA Spectrum Infusion Pump is supplied for use in general hospital settings as part of a larger system that includes safety software. It is designed to integrate with hospital medication management systems to enhance patient safety.

• What safety features does the Baxter SIGMA Spectrum Infusion Pump include?

  The Baxter SIGMA Spectrum Infusion Pump includes several safety features such as a configurable dose error reduction system (DERS), single step titration capability, flow check at run, and secondary container infusion check. These features are designed to help prevent medication errors during fluid delivery to patients.

• What is the regulatory status of the Baxter SIGMA Spectrum Infusion Pump?

  The Baxter SIGMA Spectrum Infusion Pump is authorized under FDA 510K clearance with the K-number K230022. It has been determined to be substantially equivalent to other devices in its class, specifically classified under product code FRN for general hospital use.