Early Alert: Intravascular Administration Set Issue from Baxter

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.Affected ProductThe 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. Affected devices:Product CodeProduct DescriptionLot NumbersUDI-DI1C8507Duo-Vent Solution Set and Male Luer Lock Adapter.

10 drops/ mL.109" (2.8 m). Sterile packageDR26C27062, DR26D14031, DR26E1305500085412014319What to DoDo not use affected product. Immediately identify, quarantine, and return affected lots.On June 30, Baxter sent all affected customers a letter recommending the following actions:Immediately locate, isolate, and cease all use of the affected lot numbers of the product.

The product code and lot number can be found on the individual product package and shipping carton. Contact Baxter Healthcare Center for Service to arrange for return and replacement product. If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product.

Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, and any other departments within your institution who use the affected product. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers.Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertBaxter stated that certain lots of Duo-Vent solution sets 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.Device UseThe Duo-Vent solution set is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.Contact InformationCustomers in the U.S.

with adverse reactions, quality problems, or questions about this issue should contact Baxter at (888) 229-0001.Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.