Nontuberculous Mycobacteria Infections Linked to Contaminated Heater-Cooler Units
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.Share This
Contact Our North Carolina Personal Injury Law Firm
for a Consultation for Your Accident or Medical Malpractice Claim
FOR FREE No Win, No Fee
The law firm you choose makes a difference. If you are the victim of an accident or an illness that someone else caused, the North Carolina personal injury law firm of Martin & Jones has the depth of experience, skills and sensitivity to make your road to recovery as smooth as possible. Whether you have experience with the legal system or have never hired a medical malpractice or personal injury lawyer before, our attorneys and staff will do our best to answer your questions, provide clear advice and prepare you and your family for what to expect. If you would like more information or to meet with one of our attorneys, please fill out the form below or call us at 800.662.1234.