The correction applies to all Novum IQ large volume pumps (LVP) and syringe pumps (SP). Baxter said users should consider alternate pumps if available for care involving high-risk medications and/or critical illness. However, customers can continue using the affected pump while following instructions from Baxter outlined in the FDA early alert.
Baxter reports three serious injuries and zero deaths associated with the issues with the pumps as of July 21.
The early alert comes after Baxter identified software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Multiple software anomalies can cause the blank Run screen issue. It can occur when a user attempts to silence a downstream occlusion (DSO) alarm at the same time the device is automatically restarting the infusion. This won’t interrupt ongoing therapy, which continues to completion, but the user can not adjust the ongoing therapy. This means that if the user needs to adjust therapy settings, they must interrupt their therapy.
Excessive or insufficient therapeutic effects may occur in the interim period. This can occur while either the pump door is opened or closed while the infusion is running (LVP), the syringe is reloaded while the infusion is running (SP), the pump is power cycled or the pump is replaced.
With the false motor movement system error, Baxter found a software anomaly that can occur only after the user completes specific dose or flow rate changes. This occurs when running below the minimum recommended flow rate on a syringe size of 10mL or greater. The error causes therapy interruption, which may lead to significant adverse health consequences, including serious injury or death.
Statement from Baxter
A Baxter spokesperson issued the following statement via email:
Patient safety and product quality are Baxter’s top priorities. We are working closely with and to support our customers in mitigating the potential challenges described in our field actions, and in alignment with FDA. We are confident in the Novum IQ platform and its support of safe and connected infusion therapy and are addressing the issues with great care.
The issues described in this field action only occur in specific, rare situations. We have provided customers with mitigating instructions to continue using the devices until corrective software updates are available.
Latest warning for Novum IQ pumps
Novum IQ pumps have been subject to a handful of regulatory hurdles in recent years.
Last month, Baxter issued an alert outlining an issue in which the LVP pumps have the potential for underinfusion when transitioning from a flow rate to a higher flow rate (like a rate change or bolus).
That notice came just weeks after an initial warning about potential underinfusion with all Novum IQ LVPs. The FDA identified it as the most serious type of recall, carrying the risk of injury or death. The issue affects all Novum IQ large-volume pumps, which the FDA cleared last year.
The FDA in 2023 deemed a Novum IQ SP recall Class I because the pump may incorrectly indicate the completion of an infusion. Baxter reported no serious injuries or death associated with the issue to date, though.
