Baxter’s Buretrol Solution Sets May Cause an Air Embolism
On November 8, 2012, the FDA gave Class I designation to Baxter Healthcare Corporation’s voluntary recall of Buretrol Solution Sets due to the risk the products may allow an air embolism to enter a patient’s vascular system. An air embolism can “cause serious adverse health consequences, including death.”
Buretrol Solution Sets use a ball-valve and plastic tubing to measure and administer fluids and medications into a patient’s veins. It is designed to prevent the free flow of fluids and is often used in pediatric settings, as children are less able to compensate for excess fluids and medications.
On September 7, 2012, Baxter began recalling all Buretrol Solution Sets manufactured between April 30, 2003 and July 26, 2012. According to Baxter’s recall notice, “the ball-valve component [of the Buretrol Solution Sets] is allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered.” This is highly concerning, for “[i]f the air is not removed, the air present in the tubing may enter the patient’s vascular system potentially causing air in the bloodstream (an air embolism).” An air embolism can cause shortness of breath, heart attack, stroke, or death.
A recent FDA enforcement report shows that this recall affects nearly 2 million units in distribution.
If you or a loved one has been injured or died as a result of an air embolism following the administration of fluids using a Baxter Buretrol Solution Set, you may be entitled to compensation. Burg Simpson has a national reputation as being a leader for plaintiffs and victims in personal injury litigation against medical device manufacturers. We would be happy to review your records to determine if you have a viable case. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.
