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Early Alert: Infusion Pump Issue from Baxter
The FDA is aware that Baxter has issued a letter to affected customers recommending that all Novum IQ Large Volume Pumps be corrected prior to continued use due to a potential for underinfusion when transitioning from a flow rate to a higher flow rate (e.g., rate change or bolus).
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.
As of June 27, Baxter has reported 79 serious injuries and two deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at the Baxter product feedback portal at https://productfeedback.baxter.com, by emailing Baxter at corporate_product_complaints_round_lake@baxter.com, or by phone at 800-843-7867.
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