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Malfunctioning Novum pump by Baxter leads to reported severe injury

Regular Users Tasked: Consistent and Frequent Monitoring of Patients' Infusion to Confirm Appropriate Delivery.

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Baxter issues pump recall due to one reported severe injury involving Novum model
Baxter issues pump recall due to one reported severe injury involving Novum model

Malfunctioning Novum pump by Baxter leads to reported severe injury

Baxter Novum IQ Large-Volume Infusion Pump Recall Addresses Under-Infusion Risk

Baxter, a leading healthcare company, has issued a recall for its Novum IQ large-volume infusion pump due to a critical safety issue. The pump may underinfuse or fail to deliver medication when transitioning from a lower to a higher flow rate, especially if the higher rate is more than double the lower one. This defect has been linked to several serious injuries and two reported deaths.

Impact

The main problem is underinfusion, where the drug or fluid dose delivered is less than prescribed, sometimes to the extent that no medication is delivered. This can cause serious adverse effects depending on the medication, including hemodynamic instability, cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events. The risk increases with longer infusion at the lower rate and larger magnitude of rate increase. Reports also mention overinfusion and variability caused by set misloading.

Affected Units

All Baxter Novum IQ Large Volume Pumps with product code 40700BAXUS are affected. No specific manufacturing dates or lot numbers are provided, indicating a broad potential impact across the installed base.

Baxter and the Food and Drug Administration (FDA) urge healthcare providers to change out the IV administration set or switch to another pump "at the first safe opportunity." If the set cannot be immediately changed, users should physically adjust the tubing placement before altering the infusion rate, especially when increasing flow rates or giving bolus doses. The pumps can still be used if these corrections and precautions are followed and do not require immediate return to the manufacturer.

Baxter sent letters to affected customers on July 14, 2025, with detailed guidance, emphasizing reliance on clinical judgment. Users should report any adverse events or quality issues related to the pump to Baxter via their product feedback portal or FDA MedWatch.

Background

The Novum IQ pump is used by physicians for providing intravenous infusions of large volumes of parenteral fluids, blood, and blood products to patients. In the first quarter of 2025, Baxter's U.S. infusion system business achieved double-digit sales growth. Heather Knight, chief operating officer at Baxter, stated that the company has taken market share in the low single-digit range with the Novum IQ pump.

However, this recall relates to a distinct issue from an earlier problem in April 2025, which involved underdelivery linked to the pump’s standby mode. Baxter is bringing new technology to the market with smarter, more sophisticated capabilities. The new technology includes interoperability with digital suites.

Precautions

Baxter advises users against using a programmed standby time of 2.5 hours or longer when delivering flow rates of greater than 50 mL/hour. The company also provides a poster for customers to keep with their pumps. Users are asked to monitor patients frequently to ensure the appropriate infusion is being delivered and to remove the set when they turn the pump off.

Many pumps in the market are more than a decade old. The FDA states that variability of 10% or more can put infants at risk of dehydration, inadequate drug therapy and nutrition, and insufficient blood infusion, leading to serious harm and death.

In summary, the recall addresses a serious safety hazard with underinfusion during rate transitions on the Novum IQ pumps, prompting urgent but controlled changes in pump use and infusion set management to minimize patient harm. Users are advised to follow the recommended actions and report any issues to Baxter or the FDA.

  1. The recall of the Baxter Novum IQ Large-Volume Infusion Pump is due to a critical safety issue related to underinfusion.
  2. Underinfusion can lead to serious adverse effects, depending on the medication, such as hemodynamic instability, cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events.
  3. All Baxter Novum IQ Large Volume Pumps with product code 40700BAXUS are affected by this recall.
  4. Healthcare providers are urged to change out the IV administration set or switch to another pump "at the first safe opportunity."
  5. The Food and Drug Administration (FDA) collaborates with Baxter in urging users to report any adverse events or quality issues related to the pump to Baxter via their product feedback portal or FDA MedWatch.
  6. The recall has an impact on the health-and-wellness sector and may affect Baxter's earnings and financial standing in the business world.
  7. The use of artificial intelligence (AI) and analytics in medical-device development can contribute to better patient outcomes by improving device performance and minimizing risks like the one seen in this recall event.
  8. News of this recall is significant for medtech and healthcare events as it highlights the importance of regulations and ongoing quality checks in maintaining patient safety underpinning the broader concept of health and wellness.

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