Baxter Novum Infusion Pump Warning Issued After 2 Deaths, Dozens of Injuries: FDA

Early alert has been issued for certain Baxter infusion pumps linked to nearly 80 serious injuries.

A federal warning has been issued for Baxter Novum IQ infusion pumps after two deaths were linked to dangerous dosing errors caused by flow rate problems.

The U.S. Food and Drug Administration (FDA) issued the Baxter Novum infusion pump early alert on July 22, advising that the pumps must be corrected before use due to a risk of underinfusion when transitioning to higher flow rates.

The Baxter Novum pump delivers intravenous infusions of fluids, blood and blood products under the supervision of a physician or other healthcare professional.

However, Baxter has seen an increase in reports of overinfusion and underinfusion linked to misloaded pumps, which can cause the devices to deliver fluids at dangerously incorrect rates, especially when flow rates more than double.

These dosing errors can lead to a wide range of injuries, depending on the patient’s condition, the type of therapy, and the severity of the mistake. High-risk patients are particularly vulnerable, facing potential complications such as hemodynamic instability, cardiac arrhythmias, inadequate sedation, hyperglycemia and thromboembolic events, any of which could result in serious harm or death.

The manufacturer has become aware of at least 79 serious injuries and two deaths linked to the issue, prompting the FDA to announce a safety warning for all serial numbers of Baxter Novum IQ Large Volume Pumps, with product code 40700BAXUS.

Baxter sent notification letters to affected customers outlining recommended actions on July 14. Customers were advised that if switching to a different pump and infusion set would not harm the patient, they should do so before starting an infusion or increasing the infusion rate by more than 100%.

If switching pumps is not possible, users should move the administration set down the tubing and closer to the patient before starting infusion. Additionally, users were instructed to follow the operator’s manual to ensure the infusion set is properly loaded.

Recipients should confirm receipt of the notification using the enclosed reply instruction sheet, and the communication should be forwarded to all departments using the affected infusion pumps.

For more information, Baxter can be contacted by phone at 800-843-7867, by email at corporate_product_complaints_round_lake@baxter.com, or online at https://productfeedback.baxter.com.

Baxter Infusion Pump Recalls

Baxter has faced multiple issues with its infusion pumps posing risks to patient safety. In 2020, over half a million infusion pumps were recalled due to corrosion and cleaning problems. In 2021, another recall occurred following reports of sudden pump failures. 

The following year, a safety alert was issued after three deaths were caused by alarm failures on certain pumps, which led to a recall of more than a quarter million devices. In 2023, additional pumps were recalled over 100 reports of false alarms, resulting in at least three serious injuries.

Earlier this month, a recall was issued due to a software mismatch between two pump models.

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