FDA Issues Alert Regarding Recalled Baxter Solution Sets

The FDA has issued an alert regarding “certain lots of Solution Sets with Duo-Vent Spikes” from Baxter Healthcare needing to be removed from use due to a “potentially high-risk device issue.”

Baxter had sent an Urgent Medical Device Recall letter recommending that stock be checked for certain affected product and lot numbers, which the FDA listed in their alert. The FDA also says they are “currently collecting information about this potentially high-risk device issue.”

Baxter’s report states that “some Solution Sets with Duo-Vent Spikes 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. 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 solution sets are used “to administer fluids from a container to patients through a vascular access device, such as an infusion pump. The slide clamp is a feature of these solution sets designed to shut off fluid flow and interact with the infusion pump to load the set into the pump correctly.”