The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
The US Food and Drug Administration (FDA) has issued an early alert about a potentially high-risk issue with Baxter’s Novum IQ infusion pump, citing reports of 79 serious injuries and two deaths associated with the device.
The FDA notes in the alert that it is aware Baxter has issued a letter to affected customers recommending that all Novum IQ large volume pumps be corrected prior to continued use.Â
Baxter recommends changing out the administration set or changing to another pump with a new administration set at the first safe opportunity to do so. If the delay associated with changing the pump and/or infusion set is unacceptable, users should move the administration set downstream approximately 0.5 inches prior to initiating a bolus infusion or a rate change of greater than 100%.
How the Infusion Pump Malfunction Occurs
Baxter stated that the Novum IQ large volume pump has a potential for underinfusion when transitioning from a flow rate to a higher flow rate. Specifically, the risk occurs when the second flow rate is more than double the first flow rate. The level of underinfusion is variable and is based on the lower infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change.
The longer duration the pump has been running at the lower infusion rate and the larger the magnitude of the rate change, the larger the underinfusion would be. In the worst case, no delivery may occur.
Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed.
The adverse effects that may result from underinfusion, overinfusion, and non-delivery of the intended solutions or medications range from minor or temporary harm to severe harm, depending on the patient, the condition being treated, and the fluid, drug, or other treatment being administered. High-risk and vulnerable patients may experience serious adverse health consequences, including hemodynamic instability, cardiac arrhythmias, insufficient sedation, hyperglycemia, and thromboembolic events, among others.
The Baxter Novum IQ Syringe Pump is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.
