FDA publishes Baxter update to Novum IQ infusion pump instructions addressing underinfusion risk

Editor's Note

Baxter has issued a correction notice for its Novum IQ Large Volume Pump (LVP) after identifying a serious risk of underinfusion linked to the device’s standby mode and power-off conditions. First published on April 24 on the Food and Drug Administration (FDA) website and subsequently reported by Healthcare Purchasing News on June 6, the FDA has classified the action as a recall that “involves updating instructions for using devices [but] does not involve removing them from where they are used or sold.”

Baxter’s notice to customers warns that at flow rates greater than 50 mL/hour, the programmed standby time must not exceed 2 hours and 30 minutes. If exceeded, and especially when the device is powered off without removing the administration set, the pump may deliver significantly less fluid on the subsequent infusion. This issue, the company explains, is due to compression of the set inside the pump, leading to flow rate variability and, in worst cases, up to a 50% reduction in infusion at high flow rates.

While no deaths have been reported, Baxter has confirmed one serious injury tied to this malfunction. The updated guidance includes posting an informational poster near all Novum IQ LVP units, removing sets when powering off the device, and closely monitoring patients—especially pediatric patients—who are at greater risk of harm from even modest infusion deviations.

This is the second issue involving Baxter infusion technology in recent months. As detailed in an earlier FDA alert from March 5, Baxter also recalled certain Sigma Spectrum Infusion System V6 units due to potentially missing motor mounting screws introduced during servicing. That recall required facilities to remove affected devices from use and return them for inspection. Risks included incorrect or interrupted therapy, and one serious injury was reported.

In the current case, while the Novum IQ LVP devices are not being physically recalled, they must be used under new, stringent protocols. The FDA has emphasized the need to strictly follow Baxter’s updated instructions to avoid adverse outcomes, especially when delivering critical therapies such as IV drugs, blood products, or parenteral nutrition.