Baxter has warned users of its Novum IQ large volume infusion pump about a serious safety issue linked to 79 injuries and two deaths, according to the FDA. The company urged healthcare providers to replace the pump and infusion set when it is safe to do so, without delaying critical treatment.
Problems include underinfusion, overinfusion, and non-delivery of fluids or medications—caused by issues like misloading of the tubing or sudden flow rate changes. These malfunctions may lead to serious outcomes, such as cardiac complications, poor sedation, or thromboembolic events.
While Baxter launched the Novum IQ LVP in April 2024 with strong market performance, concerns have grown since a June correction letter and an FDA recall regarding infant dehydration risks. The latest alert is more severe and widespread. The FDA continues to monitor the situation, as Baxter aims to grow its market share amid competition from devices like BD’s Alaris pumps.
28-07-2025