FDA shares warning about certain IV administration sets—heart patients face greatest risk

The U.S. Food and Drug Administration (FDA) has shared an alert about a safety issue with specific lots of Baxter’s Duo-Vent Intravascular (IV) Administration Set. The devices, designed to assist clinicians with administering IV fluids into a patient’s vascular system, may contain tiny air bubbles in the drip chamber and tubing that can enter the patient’s bloodstream. 

“If an infusion pump with an air-in-line detector is not in use—as may be the case during pressure infusions—there is a potential for air to be delivered through the IV line to the patient,” according to the alert. “In most cases, small amounts of air are absorbed in the lungs without causing harm. However, in patients with certain cardiac or vascular conditions (such as a patent foramen ovale or other right-to-left shunts), the presence of air in the circulation may lead to serious adverse events, including stroke, myocardial ischemia or death.”