The Stöckert 3T Heater-Cooler System was designed to control the body temperature of patients during cardiothoracic surgeries. However, the use of this system has been linked to nontuberculous mycobacterium (NTM) infections in these patients, leading to prolonged treatment for the infection and, in some cases, death. Approximately 60 percent of heart bypass procedures performed in the United States have been performed using heater-cooler devices that have been associated with these infections.
The U.S. Food and Drug Administration (FDA) believes that NTM may grow in the water tank of heater-cooler units. This contaminated water may then become aerosolized into the air in the operating room and, ultimately, a patient’s open chest cavity or onto an implantable device. The Centers for Disease Control and Prevention (CDC) believes these devices might have been contaminated during manufacturing, and the FDA recently warned the manufacturer, LivaNova PLC, about safety violations in its manufacturing facilities.
Importantly, while some hospitals are taking efforts to notify their patients of a potential issue with the Stöckert 3T Heater-Cooler System, patients with NTM infections often do not immediately show symptoms. In fact, an infection may not develop for several months or even years. Possible signs of an NTM infection include fatigue, fever, pain, nausea, and vomiting, as well as typical signs of infection at the surgical site, such as redness, heat, or pus.
Lawsuits are being filed against the manufacturer of the Stöckert 3T Heater-Cooler System. If you or a loved one has contracted an NTM infection following cardiac surgery, please contact our office to discuss your legal options with one of our attorneys.