Devices

FDA Alert on Baxter’s Infusion Pump

FDA has issued an early alert highlighting serious safety concerns with Baxter's Novum IQ large volume infusion pump, following reports of underinfusion, overinfusion, and two patient deaths. According to Baxter, the device may deliver insufficient medication or fluids when transitioning from a lower to a significantly higher flow rate — such as during a rate increase or a bolus. The issue appears most pronounced when the second flow rate is more than double the initial rate, according to the alert. The extent of the underinfusion depends on how long the pump was running at the initial rate and how large the increase is. In severe cases, the device may fail to deliver any medication at all.

Compounding the risk, Baxter says it has also seen a rise in reports of overinfusion and underinfusion stemming from improper loading of the infusion set tubing. If the tubing is not correctly positioned in the pump, it may infuse fluids at rates much higher or lower than intended.

These malfunctions pose significant risks to patients, particularly those who are critically ill or medically fragile, the alert says. Potential adverse effects range from minor complications to life-threatening events such as cardiac arrhythmias, hemodynamic instability, inadequate sedation, thromboembolic events, and hyperglycemia. To date, it says Baxter has reported 79 serious injuries and two deaths potentially linked to the infusion pump issues.

The syringe pump is designed for intravenous delivery of fluids, medications, and blood products under the supervision of licensed medical professionals, according to Baxter.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome