Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) are software-controlled infusion pumps that deliver controlled amounts of fluids such as pharmaceutical drugs, blood and blood products, and other required therapies. The fluids are provided through infusion into a vein or other cleared route. These infusion pumps are used in hospitals and other healthcare facilities.

Baxter is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to increased reports of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively.

False upstream occlusion alarms cause interrupted or delayed therapy and contribute to clinician fatigue, which may cause serious adverse health consequences, especially for people receiving life-sustaining medications.

Use of these products may lead to serious injury or death.

Baxter reports 131 complaints, three serious injuries, and no deaths related to this issue.

On June 15, 2023, Baxter sent affected customers an Urgent Medical Device Correction letter with the following recommendations related to pumps with software version v8.01.01 or v9.02.01:

The letter also notes that a Baxter representative will contact facilities to determine the correction plan and schedule a no charge software reversion for all affected pumps to the previous software version, v8.01.00 or v9.02.00. The representative will help facilities determine a list of affected serial numbers.

The software versions v8.01.01 and v9.02.01, the subject of this recall, were created to address a previous Class I recall for versions v8.01.00 and v9.02.00 that presented a risk of these pumps not alarming for repeated upstream occlusion events.

Baxter is working to fix the issue repeated upstream occlusion alarm issue present in software versions v8.01.01 and v9.02.01. Until a fix can be implemented, all recommendations for the relevant software versions should be followed.

Customers with questions about this recall should contact their Baxter sales representative or Baxter Global Technical Services at 800-356-3454 (choose option 3).

Medical Device Recall Database entry

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.

08/01/2023