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Medical Device recall – Infusion Pumps recalled due to this reason

Baxter previously communicated External Link Disclaimer this information to customers via an Urgent Safety Communication notification on December 29, 2021.

The Health Master

February 27, 2022

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Last Updated on January 14, 2024 by The Health Master

Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ Medical Device – infusion pumps.

Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication, in some cases without alerting the user via pump alarm.

Baxter previously communicated External Link Disclaimer this information to customers via an Urgent Safety Communication notification on December 29, 2021.

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Customers notified Baxter that the pump was not delivering medication at the programmed rate displayed on the screen, and in some cases was not alarming for upstream occlusions.

As described in the Urgent Safety Communication notification, after an upstream occlusion alarm, it is imperative to fully resolve any upstream occlusion before restarting the pump.

Failure to do so may cause the pump not to re-alarm as expected, which can lead to interruption in therapy and/or under-infusion.

The potential harm to the patient depends on several factors such as length of therapy delay, medication being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities.

To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms.

Baxter will issue a follow-up letter to customers to communicate further details on the actions being taken to address this issue.

Spectrum V8 and Spectrum IQ are distributed in the United States, Puerto Rico, Canada and certain Caribbean islands.

Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time.

Any adverse events experienced with the use of these products may be reported using one of the following options:

Calling Baxter Product Surveillance at 800-437-5176 Monday through Friday between 8 a.m. and 5 p.m. Central Time.
Emailing Baxter at: corporate_product_complaints_round_lake@baxter.com.
Reporting to the FDA MedWatch Adverse Event Reporting Program:
- Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch/.
- Regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.

Baxter is voluntarily issuing this Urgent Safety Communication with the knowledge of the U.S. Food and Drug Administration.

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