FDA issues safety alert for Baxter Novum IQ large volume pumps

Editor's Note

The US Food and Drug Administration (FDA) issued an early alert for Baxter’s Novum IQ Large Volume Pumps (Model 40700BAXUS) due to potential for underinfusion when transitioning from a flow rate to a higher flow rate (eg, rate change or bolus).  

According to the agency’s July 22 announcement, the pump may deliver no fluid at all in the most severe cases. Baxter also reports an increase in dosing errors linked to misloaded administration sets, which can cause infusions to run faster or slower than programmed. Potential consequences include hemodynamic instability, cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events. As of June 27, Baxter has reported 79 injuries and two deaths potentially related to these issues.

When clinically appropriate, users should switch to a different pump and administration set before initiating a bolus or making large rate changes. If switching is not feasible, the administration set should be repositioned downstream by 0.5 inches following Baxter’s specific instructions. The full FDA alert includes detailed mitigation steps and additional information.