Baxter issues product recall for specific Novum pumps due to complications linked to 79 reported injuries and 2 fatalities.
The Baxter Novum IQ large volume infusion pump, a key product in Baxter's bid to expand its share of the infusion pump market, has encountered widespread issues that could potentially lead to underinfusion or overinfusion of medications during rate transitions. These problems have resulted in 79 serious injuries and 2 deaths reported to the FDA as of June 2025.
The issues, particularly when increasing the flow rate more than double the previous rate, can cause variable under-delivery, including cases where no drug is delivered at all. This poses a significant risk to patient safety, with potential adverse effects ranging from minor or temporary harm to severe injuries such as hemodynamic instability, cardiac arrhythmias, and other severe health issues.
The problem arises primarily during transitions from a low flow rate to a higher flow rate, with the underinfusion magnitude depending on the duration at the lower rate and the degree of rate increase. Misloading of the IV administration set tubing can worsen over- or underinfusion. Testing showed infusion variability exceeding 10%, potentially reaching 50% underinfusion at high flow rates (up to 1200 mL/hour) and extended standby times.
In response, both Baxter and the FDA have issued safety alerts, urging healthcare providers to change the IV administration set or switch to another pump at the first safe opportunity. If changing the set is not immediately possible, manual adjustment of tubing placement before altering drug delivery rates is recommended. Clinical judgment should be relied upon when managing affected devices.
Baxter has contacted users of the Novum IQ large volume pump and advised them to change the pump and infusion set at a time when a delay in treatment would not harm the patient. The company has also provided recommendations for healthcare professionals who cannot change the pump without causing an unacceptable delay in infusion.
The FDA published an early alert about the issue, followed by a recall notice in June after Baxter issued a correction letter for the Novum IQ large volume pump, advising users on how to prevent underinfusion. Baxter has already recommended actions to mitigate the risk of underinfusion, overinfusion, and non-delivery of medications or fluids to its customers.
The launch of the Novum IQ large volume pump had initially gone well, with the product performing strongly, according to Baxter CFO Joel Grade. However, the recent problems have highlighted the importance of careful monitoring and prompt action when using the Novum IQ large volume pumps.
The FDA has stated that underinfusion, overinfusion, and non-delivery of medications or fluids can cause adverse effects ranging from minor or temporary harm to severe injuries. Potential adverse effects include cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events.
As Baxter works to increase its share of the market served by rival devices, including BD's Alaris pumps, the company remains committed to addressing the issues with the Novum IQ large volume pump and ensuring the safety of its users.
- The regulatory body, FDA, has published an alert about the potential issues with Baxter's Novum IQ large volume infusion pump, which could lead to underinfusion or overinfusion of medications during rate transitions.
- Underinfusion, particularly during transitions from a low flow rate to a higher flow rate, can pose a significant risk to patient safety, potentially causing severe health issues like hemodynamic instability, cardiac arrhythmias, and other severe injuries.
- Baxter, in response to these issues, has issued a safety alert, advising healthcare providers to change the IV administration set or switch to another pump at the first safe opportunity.
- Testing showed infusion variability exceeding 10% on the Novum IQ large volume pump, potentially reaching 50% underinfusion at high flow rates.
- The FDA has also published a recall notice for the Novum IQ large volume pump, following a correction letter issued by Baxter, advising users on how to prevent underinfusion.
- Baxter has already recommended actions to mitigate the risk of underinfusion, overinfusion, and non-delivery of medications or fluids to its customers, including changing the pump and infusion set.
- In the realm of health and wellness, it's crucial for medical device companies like Baxter to prioritize patient safety and carefully monitor their products for any potential issues, such as those encountered with the Novum IQ large volume pump.
