FDA issues early alert on Baxter infusion pumps after 3 serious injuries
The U.S. Food and Drug Administration (FDA) has issued an early alert on infusion pumps made by Baxter, due to software errors that can be triggered during operation. Specifically, on impacted Novum IQ pumps, silencing the downstream occlusion while the device is restarting its infusion cycle can cause the “run” screen to go blank, or trigger a system error.
According to Baxter, the blank screen will not interrupt infusion; however, it will leave users unaware of what is happening and unable to make adjustments. The other error, a false motor movement, will interrupt therapy outright and require a full reset.
The Baxter Novum IQ pumps are used in a variety of healthcare settings to provide intravenous infusion of fluids or blood to a patient, under the direction or supervision of clinical staff. Because of the serious issues that can occur as a result of a botched infusion—ranging from delayed care to too much or too little fluid reaching a patient—this alert is being designated as potentially high risk by the FDA.
While there have been no deaths associated with the errors, Baxter has reported three serious injuries.
No pumps need to be removed from care settings. However, all operators must follow a set of updated use instructions to perform an infusion safely.
What devices are impacted?
The following Novum IQ LVP and Novum IQ Syringe Pumps are subject to the alert and the updated use instructions:
Next steps
Baxter and the FDA recommend all hospitals and clinics use alternative pumps, if available—especially for patients receiving high-risk medications or who may be critically ill.
However, Novum IQ pumps with the software error can still be used safely by following an additional set of precautions:
- If a blank “run” screen appears on the Novum IQ LVP during infusion, open the door, press the tubing into load points 3 and 4 until the light turns green, then close the door.
- For the Novum IQ Syringe Pump, unload and reload the syringe.
- If the issue persists on either pump, power-cycle the device, select “yes” at the new patient prompt, and reprogram the infusion.
To prevent a false motor movement system error, do not program the Novum IQ Syringe Pump to infuse below the minimum recommended flow rate for syringe sizes of 10 mL or greater. Error codes 20602 and 20603 indicate this issue.
For more information on this issue—including how different syringe sizes may trigger the error based on infusion settings—see the full alert.
Baxter asks that customers review a letter it sent on July 21, which includes additional details. Both the company and the FDA request that this notice be shared with other providers and healthcare organization.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.