This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.

Affected Product

Affected Product:

What to Do

On April 24, Baxter sent all affected customers a letter recommending the following actions:

• 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.
• Please remove the set upon powering off the device.
• Post the enclosed informational poster with Novum IQ LVPs in your facility.
• Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product.

Reason for Updates to Use Instructions

Baxter has become 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.

Testing has identified that at flow rates above 50 mL/hour, certain infusions may experience flow rate variability of more than 10% after 2 hours and 30 minutes. In the worst-case scenario, 50% underinfusion can be observed at the maximum flow rate of 1200 mL/hour and the maximum standby time of 12 hours. This may lead to underinfusion of infusates, including drugs, IV nutrition, blood, and blood products.

Note that even at 10% variability, pediatric patients (infants > 29 days to 2 years) may be at risk of dehydration, inadequate drug therapy and nutrition, as well as insufficient blood infusion, leading to increased risk of morbidity and mortality.

Baxter has reported one serious injury, and no deaths associated with this issue.

Device Use

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.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at 847-948-4770.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.