The U.S. Food and Drug Administration and the Center for Disease Control and Prevention have issued warnings concerning an increased risk of infection from heater-cooler devices used during open heart and transplant surgery. Heater-cooler devices are used during heart and transplant surgery to heat and cool a patient’s blood and organs to maintain optimum body temperature during surgery. Defective heater-cooler devices have been linked to nontuberculous mycobacteria (NTM) infections. Symptoms may not appear for weeks or even years and may lead to serious illness or death.
The CDC recommends that patients who have undergone open heart or transplant surgery should seek medical care for symptoms such as fever, night sweats, nausea, vomiting, swelling, fatigue, weight loss, and muscle/joint aches. Patients who have undergone heart and transplant surgeries are especially susceptible to contracting the bacterial infection due to compromised immune systems.
The Sorin Stocket 3T was the first device approved in the U.S and continues to be the most popular heater-cooler device on the market. In late 2015, FDA investigators inspected a Sorin Stocket 3T manufacturing facility in Munich, Germany and found that contamination of the devices likely occurred during the manufacturing process. The FDA noted several violations and issued a warning letter stating that the company failed to validate a new process for disinfection of the devices which likely led to transmission of mycobacteria.
If you are your loved one has been injured by a heater-cooler device, you may be eligible for compensation. Martin & Jones is investigating heater-cooler claims and filing lawsuits on behalf of injured individuals. Call 800.662.1234 or reach us by email.