Baxter infusion pumps face another Class I recall, this time for possible false alarms

For the third time in the last two years, Baxter has been hit with the FDA’s most serious label for a recall affecting its infusion pump systems.

This time around, the Class I recall notice is linked to thousands of the company’s infusion pumps that are equipped with certain versions of drug library software: Sigma Spectrum pumps using version 8 of the Master Drug Library and Spectrum IQ pumps running with version 9 of the Dose IQ software.

Both of the recalled pumps rely on their respective drug-dosing software to help mete out specified amounts of therapeutics, blood and other needed fluids to hospitalized patients via IV.

The recall covers nearly 23,000 of the infusion pumps that were distributed in the U.S. between the end of September 2015 and early May of this year.

Baxter began the recall in mid-June after receiving an uptick in reports of false upstream occlusion alarms from the pumps. The reports were linked to recent upgrades to versions v8.01.01 and v9.02.01 of the Master Drug Library and Dose IQ software, respectively.

Upstream occlusions block fluids from traveling smoothly from an IV bag to an infusion pump, so, if the system issues an upstream occlusion alarm, a patient’s treatment may be delayed or paused while the suspected issue is investigated—unnecessarily so, if it turns out to be a false alarm.

In addition to interrupting much-needed and often life-sustaining therapy, those false-alarm-induced stoppages could also contribute to clinician fatigue, according to the FDA, “which may cause serious adverse health consequences.”

So far, per the agency’s notice, Baxter has received more than 130 complaints related to the recall, including three reports of serious injuries. No patient deaths have been linked to the recall.

Baxter has advised hospitals using its infusion pumps with the specified software versions that they may continue using the systems as long as they follow all on-screen directions and the setup instructions listed in the operator’s manual.

Company representatives are in the process of contacting those facilities to schedule a software fix that’ll return the Master Drug Library or Dose IQ software to its previous version at no cost to the hospital. In the meantime, Baxter warned that false alarms may continue until the software reversion is complete; if an alarm is found to be false and can’t be resolved, clinicians should unload and reload the infusion set.

The now-recalled versions of both drug-dosing software programs were themselves originally meant to be a fix for Baxter’s last Class I infusion pump recall. In that case, the versions 8.01.00 and 9.02.00, respectively, of Master Drug Library and Dose IQ—to which the current software reversion efforts will now return—were found to have the opposite issue: Users reported that the pumps would sometimes not issue an alert at all if an upstream occlusion actually occurred.

That recall, which covered more than 277,000 devices sold in the U.S. between 2015 and 2022, sparked reports of more than 50 serious injuries and three patient deaths.

With the latest recall now returning infusion pumps systems to that version of the software, Baxter has directed clinicians to the recommendations it issued alongside the previous recall—including following all listed instructions and taking care to fully clear all occlusions before restarting a pump.