FDA Alert on Baxter Solution Sets

FDA has issued an alert against the use of certain Baxter Solution Sets with Duo-Vent Spikes because they were incorrectly assembled with inverted slide clamps. “If a solution set with an inverted slide clamp is loaded on an infusion pump, the medication may not be delivered and the patient’s blood may backflow into the set and source container,” the alert says. “Critical adverse health consequences may occur if the patient does not receive life-sustaining medication or if a significant amount of blood is removed from the patient, especially for high-risk populations, such as neonates or critically ill patients.” The alert includes the lot numbers of affected products.

The devices are intended for administering fluids from a container to patients through a vascular access device (e.g., infusion pump). The slide clamp is a feature on the sets and is designed to shut off fluid flow and interact with the infusion pump to load the set into the pump correctly, the alert says.