On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.
In the recall, Baxter Healthcare Corporation said false upstream occlusion alarms cause interrupted or delayed therapy and contribute to clinician fatigue, which may cause serious adverse health consequences, especially for patients receiving life-sustaining medications. Use of the recalled products may lead to serious injury or death. To date, Baxter Healthcare Corporation has received 134 reports, three of which involved serious injuries. However, no deaths related to the issue were reported.
The recall affects 22,769 pumps distributed from September 29, 2015–May 2, 2023, in the United States and Puerto Rico. The recalled product codes are 35700BAX2 and 3570009.
The software versions v8.01.01 and v9.02.01, the subject of the recall, were created to address a previous class I recall for versions v8.01.00 and v9.02.00 that presented a risk of the pumps not alarming for repeated upstream occlusion events.
If the infusion pumps use software version v8.01.01 or v9.02.01, Baxter Healthcare Corporation said that consumers should follow the recommendations listed. If the infusion pumps use software version v8.01.00 or v9.02.00, consumers should refer to Baxter Healthcare Corporation’s prior recommendations for the class I recall surrounding pumps not alarming for repeated upstream occlusion events.
On July 28, 2023, Baxter Healthcare Corporation issued an urgent medical device correction to revert Spectrum V8 and Spectrum IQ infusion pumps that have been upgraded to software versions v8.01.01 and v9.02.01. Baxter Healthcare Corporation is contacting affected consumers to schedule software reversion on all affected pumps.
Until the reversion is completed, consumers can continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions or referencing the section about alarms in the operator’s manual, but false alarms may occur. If a consumer is unable to resolve an upstream occlusion alarm, Baxter Healthcare Corporation said they should unload and reload the set.
Consumers with additional questions can contact their Baxter Healthcare Corporation sales representative or Baxter Technical Assistance at 800-356-3454, option 3, Monday–Friday from 6 am–6 pm CST. They should report any adverse events related to the use of the affected products by email to Baxter Healthcare Corporation and to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.