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Early Alert: Intravascular Administration Set Issue from Baxter
The FDA is aware that Baxter has issued a letter to affected customers recommending certain Duo-Vent solution sets be removed from where they are used or sold. Baxter has identified certain lots of Duo-Vent solution sets that may have air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
This issue may result in air entering the administration set when pressure is applied to the bag (e.g., via a pressure cuff) or when the tubing is flushed while fully open. 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.
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.
As of July 15, Baxter has reported no serious injuries or deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public 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 issue should contact Baxter at (888) 229-0001.
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