Baxter Healthcare Corporation Recalls Novum IQ Syringe Pump for Potential Underdosing
Please be aware, this recall is a correction, not a product removal.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: Novum IQ Syringe Pump
- Product Codes: All Serial Numbers - See Recall Database Entry
- Distribution Dates: March 10, 2023 to August 16, 2023
- Devices Recalled in the U.S.: 2,023
- Date Initiated by Firm: September 21, 2023
Device Use
The Novum IQ syringe pump is an infusion pump, intended to help deliver an accurate amount of fluids, whether nutrients or medications, into a patient's body in a controlled manner. The device is suitable for patient care in hospitals and outpatient healthcare facilities for use on adults, pediatrics, and neonates by trained health care professionals.
Reason for Recall
Baxter Healthcare Corporation is recalling the Novum IQ Syringe Infusion Pump because the pump may indicate an infusion is complete when it is not. The problem has been traced to a software error that may miscalculate volume after the pump detects a blockage (occlusion).
Use of the pump could lead to serious adverse health consequences and death. People treated with the infusion pump might not get enough of the fluids they need, or time-sensitive treatment could be delayed. Underdosing or delays could lead to serious adverse health consequences, especially for people receiving life-sustaining medications. In high-risk populations, insufficient fluid delivery could lead to death.
There have been no reports of serious injury or death associated with the software problem.
Who May be Affected
- Patients who require an infusion in a hospital or medical facility using the Novum IQ Syringe Infusion System.
- Health care providers who provide infusion therapy using the Novum IQ Syringe Infusion System.
What to Do
On October 13, Baxter Healthcare Corporation sent all affected customers an Urgent Medical Device Correction letter.
The letter requested customers to:
- Monitor the remaining fluid in the syringe after an infusion has completed, especially when one or multiple downstream occlusions have alarmed
- If the total dose is not delivered upon the "Infusion Complete" alarm, users should reprogram the pump and deliver the remaining volume as necessary.
- Wait for a Baxter representative to contact your facility once the software upgrade becomes available.
- Acknowledge receipt of the correction letter by responding on the Baxter customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com even if there is no remaining inventory.
Contact Information
Customers in the U.S. with questions about this recall should contact Baxter Global Technical Services at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Additional Resources
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 using an online form, regular mail, or FAX.