Heater-cooler devices are used during surgery to warm or cool the patient. They are primarily used in cardiothoracic procedures, such as open heart surgery, but are sometimes used in other types of surgery. 3T Heater-Cooler Systems have been linked to nontuberculous mycobacterium (NTM) infections. NTM infection can be fatal. Patients who have been exposed may not show symptoms for months or years, allowing NTM to spread and making it difficult or impossible to completely clear the body of infection.
FDA Recommends Discontinuing Use of Certain 3T Systems
The U.S. Food and Drug Administration (FDA) initially believed that the infections were a problem with heater-cooler systems in general. Then, in 2014, M. chimaera was discovered at a Sorin 3T production facility, on the production line and in the water supply. The company took action to clean up the production line in September, 2014.
In June, 2016, the FDA issued a warning stating that the NTM infections it had received reports of were linked to the Sorin 3T Heater-Cooler System rather than a problem with heater-cooler systems in general.
In October, 2016, the FDA issued an update to its June warning, recommending that medical facilities stop using 3T Heater-Cooler Systems manufactured prior to September, 2014, except in emergencies and life-threatening situations where no other device is available.
How Heater-Cooler Systems Spread Infection
Heater-cooler systems provide temperature controlled water to heat exchangers or warming/cooling blankets. The water does not come in contact with the patient when being delivered to these components, but can be blown out through the exhaust vent, into the air and onto the patient. If the water is contaminated, the patient is exposed.
You May Be at Risk
Patients who have undergone surgery involving a contaminated heater-cooler device may be infected and not know it. Symptoms may not appear for months or years. The FDA recommends that people who have had cardiopulmonary bypass surgery talk to their doctors to determine if they need testing or monitoring for NTM infection, even if they are not experiencing symptoms. The agency says you should be on the lookout for NTM symptoms including:
- Abdominal pain
- Joint pain
- Muscle pain
- Redness, puss or heat at the surgical site
- Weight loss
- Night sweats
If you or someone you love developed an infection after cardiac bypass surgery or other surgery using the 3T heater-cooler system, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.