Spectrum IQ Infusion System with Dose IQ Safety Software

• • Ongoing Z-2415-2025 FDA Class II ·initiated 14 Jul 2025

  Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

• • Ongoing Z-1254-2025 FDA Class I ·initiated 5 Feb 2025

  There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

• • Ongoing Z-0348-2025 FDA Class II ·initiated 2 Oct 2024

  The door on the Spectrum IQ Infusion pump may not be able to fully close.

• • Ongoing Z-2582-2024 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-1810-2024 FDA Class II ·initiated 9 Apr 2024

  There is a potential for cracks on the mount of the front panel of the device.

• • Ongoing Z-1775-2024 FDA Class II ·initiated 20 Mar 2024

  One device was improperly performed testing prior to release from a Service Center.

• • Ongoing Z-2104-2023 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.

510(k) Number

K230041 ↗

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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• What types of infusions can the Spectrum IQ Infusion System administer, and how does it differ from standard infusion pumps?

  The Spectrum IQ Infusion System is designed to administer a wide range of fluids, including pharmaceutical drugs, blood, blood products, and enteral nutrition. Unlike standard infusion pumps, it integrates Dose IQ Safety Software, a web-based platform that enhances safety by automating drug library compliance, protecting high-risk infusions, and streamlining clinical workflows. It supports both large-volume infusions (e.g., IV fluids) and syringe-based infusions, making it versatile for various clinical needs in general hospital settings.

• Is the Spectrum IQ Infusion System reusable, and what does that mean for maintenance and cleaning?

  Yes, the Spectrum IQ Infusion System is supplied as a reusable medical device. This means it is intended for repeated use across multiple patients, provided it undergoes proper cleaning, disinfection, and maintenance as outlined in Baxter’s instructions for use. Reusability requires adherence to sterile or non-sterile handling protocols depending on the specific infusion application, though the device itself does not claim explicit sterility.

• How does the Dose IQ Safety Software improve workflow efficiency compared to traditional infusion systems?

  The Dose IQ Safety Software centralizes drug library management, allowing clinicians to automate programming for common infusions and reduce manual errors. It integrates across infusion modalities, ensuring compliance with drug libraries and high-risk infusion protocols. This web-based platform helps standardize workflows, minimize interruptions, and improve safety by flagging potential issues before administration.

• What regulatory pathways does the Spectrum IQ Infusion System follow, and how does that affect its use in hospitals?

  The Spectrum IQ Infusion System is classified as a Class II device under FDA 510(k) clearance and adheres to MDR (Medical Device Regulation) standards. This classification means it has undergone rigorous review to demonstrate substantial equivalence to predicate devices, ensuring it meets safety and performance requirements for use in general hospital settings. Hospitals can rely on its regulatory approvals when integrating it into clinical workflows.