Early Alert: Infusion Pump Issue from Baxter

Early Alert: Infusion Pump Issue from Baxter

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware Baxter has issued a letter to affected customers recommending that all Novum IQ Large Volume Pumps be corrected prior to continued use:

Product Code

Product Description

Serial Numbers

UDI-DI Number

40700BAXUS

Novum IQ LVP

All

05413765851797

What to Do

Change out the administration set or change to another pump with a new administration set at the first safe opportunity to do so. If the delay associated with changing the pump and/or infusion set is unacceptable, users should move the administration set downstream approximately 0.5 inches prior to initiating a bolus infusion or a rate change of greater than 100%.

On July 14, Baxter sent all affected customers a letter recommending the following actions:

• Users should rely on their clinical judgment. When the delay associated with changing the pump and infusion set would NOT prove detrimental to the patient, users should change out the pump and infusion set prior to initiating a bolus infusion or a rate change of greater than 100%.
• If the delay associated with changing the pump and/or infusion set would prove unacceptable, prior to initiating a bolus infusion or a rate change of greater than 100%, users should move the administration set downstream (towards the patient) approximately 0.5 inches by following these steps:
  • Please follow the instructions for unloading the set in section 4.4, Unloading an Administration Set, of the Novum IQ LVP Operator’s Manual.
  • To prevent free flow, ensure downstream roller clamp is fully closed.
  • Once unloaded, move the administration set downstream by moving the slide clamp toward the container by 0.5 inches.
  • After moving the slide clamp, reload the administration set. Please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the Novum IQ LVP Operator’s Manual.
  • Once the tubing has been loaded, the door closed and the slide clamp has been ejected, ensure that the downstream roller clamp is fully open.
  • Initiate replacement of the administration set at the first safe opportunity to do so, or check regularly to ensure the infusion proceeds at the expected rate.
• To prevent misloading, please follow the instructions for loading the set in section 4.3, Loading an Administration Set, of the Novum IQ LVP Operator’s Manual.
• Consistent with the instructions for use, customers should ensure that:
• The door is fully open before loading the set.
• The tubing is taut and loaded without slack in the pumping channel as pictured below.
• Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory.
• Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, Director of Anesthesia, and any other departments within your institution who use the affected product.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Alert

Baxter stated that the Novum IQ large volume pump (LVP) has a potential for underinfusion when transitioning from a flow rate to a higher flow rate (e.g., rate change or bolus). Specifically, the risk occurs when the second flow rate is more than double the first flow rate. The level of underinfusion is variable and is based on the lower infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. 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 underinfusion would be. In the worst case, no delivery may occur.

Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed.

The adverse effects that may result from underinfusion, overinfusion, and non-delivery of the intended solutions or medications range from minor or temporary harm to severe harm, depending on the patient, the condition being treated, and the fluid, drug, or other treatment being administered. High-risk and vulnerable patients may experience serious adverse health consequences including hemodynamic instability, cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events, among others.

As of June 27, Baxter has reported 79 serious injuries and two 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 the Baxter product feedback portal at https://productfeedback.baxter.com, by emailing Baxter at corporate_product_complaints_round_lake@baxter.com, or by phone at 800-843-7867.

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.          

• Content current as of:

  07/22/2025