FDA Issues Notice About Correction to Novum IQ Large Volume Pumps

The FDA has issued a notice regarding a letter Baxter issued to customers recommending that Novum IQ Large Volume Pumps be corrected prior to continued use.

The letter specifically stated that “for flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered.” Upon powering off the device, the set should be removed. An informational poster was also distributed with the letter to be placed in facilities that use the LVPs.

Baxter became aware of the “potential for underinfusion with the Novum IQ large volume pump following use of the “standby mode” feature, or if the device is powered off with the set loaded. Keeping the administration set loaded in the pump for an extended period of time may result in an underinfusion on the subsequent infusion due to compression of the set. The risk increases when infusing at higher flow rates after longer duration in standby mode or powered off.” Flow rates above 50 mL/hour may cause flow rate variability of “more than 10% after 2 hours and 30 minutes.” Worst-case scenarios show 50% underinfusion, which “may lead to underinfusion of infusates, including drugs, IV nutrition, blood, and blood products.”

The Baxter Novum IQ Syringe Pump is “intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.”