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.

Recalled Product

• Product Names: SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9)
• Product Codes: 35700BAX2 and 3570009
• Distribution Dates: September 29, 2015 to May 2, 2023
• Devices Recalled in the U.S.: 22,769
• Date Initiated by Firm: June 15, 2023

Device Use

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.

Reason for Recall

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.

Who May be Affected

• Health care providers using SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software.
• Patients who require care using SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software.

What to Do

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:

• Continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions or infusion setup instructions in the Operator’s Manual. Relevant manual sections include:
  • Preparing the Pump and IV Sets
  • Programming the Pump
  • Alarms: Upstream occlusion alarm troubleshooting
• Note that false upstream occlusion alarms can occur at a higher rate until a software reversion is completed. If you are unable to resolve an upstream occlusion alarm, unload and reload the set.
• Acknowledge receipt of the notification (even if you do not have any remaining inventory) by responding on the Baxter customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com.
  • Log in to the portal using the account number listed in the enclosed reply form instruction sheet.
• Forward a copy of the communication to any other facilities or departments that received distributed products.

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.

• If the infusion pumps in use have the software version v8.01.01 or v9.02.01, you should follow the recommendations listed here.
• If the infusion pumps in use have the software version v8.01.00 or v9.02.00 (either due to reversion or the software was not updated from v8.01.00 or v9.02.00), you should refer to Baxter’s prior recommendations for the Class I recall surrounding pumps not alarming for repeated upstream occlusion events. These recommendations can also be found on FDA’s website.

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.

Contact Information

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

Additional Resources

• Medical Device Recall Database entry

How do I report a problem?

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.

Read the full alert.