The Stöckert 3T heating-cooling system (“3T”) has been linked to serious and sometimes life-threatening nontuberculous mycobacteria (“NTM”) infections.
Heating-cooling systems like the 3T are designed to raise or lower the temperature of a patient’s body during certain surgical procedures, most commonly open-chest cardiac procedures. These devices have water tanks that provide temperature-controlled water to heat exchangers or blankets, which then provide cooling or warmth to the patient’s body.
Testing conducted by the manufacturer in August 2014 found NTM contamination on the production line and water supply at the 3T manufacturing facility. During surgery, a contaminated device can cause harmful NTM bacteria to become airborne and enter the patient’s body through the lungs or chest cavity.
Because NTM is a slow growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection. The recommended monitoring period after exposure is at least four years. While an NTM infection diagnosed early may be successfully treated with a series of antibiotics, there is a significant risk of death in cases diagnosed late and in individuals with considerably weakened immune systems. NTM infection symptoms are often general and non-specific, and may include:
On December 29, 2015, the Food and Drug Administration (“FDA”) issued a Warning Letter to LivaNova PLC, the manufacturer of the 3T, stating that the device was adulterated, meaning that certain aspects of the device’s manufacture did not conform to federal law.
On June 1, 2016, the FDA issued a Safety Communication specific to M. chimaera infections (a type of NTM infection) associated with the use of the 3T. The FDA updated the Safety Communication on October 13, 2016, recommending, among other things, that medical facilities strongly consider discontinuing use of 3T devices.
Lawsuits are being filed against LivaNova PLC for its failure to warn hospitals and doctors of the increased risk of infections caused by the 3T device. The experienced team of pharmaceutical attorneys at Williams Cuker Berezofsky, LLC is currently investigating potential claims on behalf of patients who have developed NTM infections after open-heart surgery because of the 3T device. To learn more about the Stöckert 3T device and how we can help, call us today at 856-667-0500 or contact us online. With offices in Cherry Hill, New Jersey and Philadelphia, we represent clients nationwide.