The FDA is spotlighting a new medical device correction effort at Baxter over its large-volume Novum IQ infusion pump, following reports of 79 serious injuries and two deaths linked to potential under- or overdelivery of medications and other fluids.
The company and the agency are urging healthcare providers to change out the device’s IV administration set or switch to another pump “at the first safe opportunity to do so.” If the set cannot be changed, users should physically adjust the tubing’s placement before altering the drug delivery rate, including for bolus doses.
On July 14, Baxter alerted customers to a potential issue with the large-volume pump when transitioning from a low flow rate to a higher one, specifically when the rate change is more than double.
That could result in variable levels of under-infusion—or, in the worst-case scenario, no drug delivery at all—based on the differences between flow rates and how long the machine was running at the previous setting.
“The longer duration the pump has been running at the lower infusion rate and the larger the magnitude of the rate change, the larger the under-infusion would be,” the FDA said in its notice. Baxter has also identified customer reports of over- and under-infusion potentially due to set misloading.
The pumps can still be used following the instructions provided, and do not need to be returned to the manufacturer at this time. The FDA’s notice was issued under its pilot program for earlier device safety communications.
The issue is separate from an earlier problem identified by Baxter in April, which linked potential underdelivery to Novum IQ LVP’s standby mode, or if the device was powered off with an infusion set still loaded.
According to the agency, testing showed that maintaining flow above 50 mL/hour for longer than 2 hours and 30 minutes may lead to variability in infusion rates of more than 10%—including as much as 50% underinfusion linked to the maximum flow rate of 1200 mL/hour for the maximum standby time of 12 hours.
Editor's note: This story has been corrected and previously referred to the Novum IQ large-volume pump as a syringe pump, which is a separate model.