Patients undergoing heart surgery may be at risk of a serious or life-threatening infection if a contaminated heart surgery device is used during surgery.

Certain heater-cooler device systems have been reported as a possible risk. Any such device may allow surgical wounds to become infected.

Heater-cooler devices, like the Stöckert 3T Heater-Cooler manufactured by LivaNova PLC, are used during heart surgeries to warm and cool a patient’s blood and organs as deemed necessary.

However, the Center for Disease Control has released a warning that in the manufacturing process, certain devices may have been contaminated. Patients undergoing heart surgery may be operated on with a contaminated heart surgery device.

The use of such a contaminated heart surgery device places patients at risk of being infected with a species of nontuberculous mycobacterium (NTM).

What is Nontuberculous Mycobacterium Infection?

NTM is a serious infection that, even with proper antibiotic treatment, can last for a year. While NTM is not contagious, surgical patients may be vulnerable to developing an infection from contaminated surgical equipment.

An NTM infection is linked with specific symptoms that patients should be on the lookout for. These symptoms include night sweats, aching muscles, joint pain, weight loss, fatigue, and fever.

In some cases, symptoms of an NTM infection may remain dormant for several months after the initial infection. This means that patients may have a difficult time connecting the surgery with their infection symptoms, given the amount of time between the two.

Because of this common dissociation, diagnosis for a post-surgical NTM infection can be delayed for many months or even years.

After a 2015 report from Swiss investigators showed a link between heart surgery patients and NTM infection, both the CDC and the U.S. Food and Drug Administration published alerts about heater-cooler device systems.

According to the CDC, patients who have undergone open heart surgery since 2012 may be at risk of a potentially fatal infection due to the use of a contaminated surgical device. During this time, 28 heart surgery patients in the U.S. have been infected in such a manner, and at least 12 patients have died, the CDC reports.

Cases of infection have since been identified in Pennsylvania, Iowa, and Michigan.

The CDC has estimated that the risk of a patient being infected in this way at a hospital where this has occurred is somewhere between one in 100 and one in 1,000.

Contaminated Heart Surgery Device Lawsuits

A defective medical device class action lawsuit against LivaNova over heater-cooler device infection was filed in February 2016 in Pennsylvania. The patients involved in the lawsuit had undergone open heart surgeries in 2015.

If you or someone you love has suffered from a NTM infection after undergoing heart surgery with the use of a heater-cooler device and think a contaminated heart surgery device was the cause, you may be able to file your own claim or join a defective medical device class action lawsuit.