Baxter has recommended removal of certain Duo-Vent solution sets, which are used for the administration of fluids from a container into the patient’s vascular system through a vascular access device.
According to an FDA early alert, 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 (eg, via a pressure cuff) or when the tubing is flushed while fully open, the FDA reports. 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 FDA.
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, the FDA says.
As of July 15, Baxter has reported no serious injuries or deaths associated with this issue, the FDA reports.
Affected Devices
| Product Code | Product Description | Lot Numbers | UDI-DI |
|---|---|---|---|
| 1C8507 | Duo-Vent Solution Set and Male Luer Lock Adapter. 10 drops/ mL.109″ (2.8 m). Sterile package | DR26C27062, DR26D14031, DR26E13055 | 00085412014319 |
FDA Recommendations
According to the FDA early alert, customers are advised to not use affected product and 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.
More information is available on the FDA website.
