Devices used to keep patients warm during open-heart surgery are getting new attention from government regulators due to an associated risk of infection.

The Centers for Disease Control recently issued a warning about the Stockert 3T surgical heater-cooler system, a product of Italian company LivaNova.

The Stockert 3T heater-cooler system is used during certain kinds of open-heart surgery to keep the surgical patient properly warmed or cooled.

However, the CDC reports that this device may actually increase a patient’s risk of getting an infection.

Testing performed by the CDC found the bacteria in the devices matched bacteria found in several patients.

Some patients involved in the CDC investigation have died, though the agency cannot confirm whether their death resulted directly from their infections.

Some units of the same cardiac heater-cooler system are branded as the Sorin 3T heater-cooler system, named after German company Sorin Group Deutschland GmbH, which formerly marketed the device.

The CDC’s warning echoes an earlier warning from the FDA issued in June 2016 and updated the next October. Both warnings recommend that patients who have undergone surgery using a Stockert 3T device should be on the lookout for symptoms of a post-operative infection.

These symptoms can include (but are not limited to) nausea, vomiting, fatigue, night sweats, muscle aches, joint pain, weight loss, fever, or persistent or bloody cough.

Heater-Cooler Systems in Open-Heart Surgery

The Stockert 3T works by providing temperature-controlled water to other surgical instruments, like heat exchangers or warming and cooling blankets, that are used to control the temperature of organs or blood.

Keeping the patient’s body temperature under control during open-heart surgery helps optimize care and improve patient outcomes.

The trouble with the Stockert 3T system, according to the FDA, is that water from inside the device may carry bacteria to the patient’s body during open-heart surgery.

Normally, the water inside the device does not come into contact with the patient, but according to the FDA’s June 2016 communication, water inside the Stockert 3T system can aerosolize or find its way into other parts of the device.

From there, water can exit the device through its exhaust vent and into the air of the operating room, potentially carrying contaminants to the open surgical site on the patient’s body.

The FDA’s communication refers to a recent European study that compared clinical samples of the M. chimaera bacterium taken from several infected patients and compared them to samples taken from the German facility where the Stockert 3T is produced and serviced.

Researchers reported finding a direct link between the M. chimaera sampled and the Stockert 3T.

According to the CDC, this device is used in over 250,000 bypass surgeries performed in the U.S. every year – about 60 percent of the total number of bypass surgeries.

The FDA updated its warning in October 2016 with specific instructions for health care providers on how to reduce the risk of M. chimaera infection associated with the Stockert 3T system.

At the same time, the agency warned that while M. chimera infections may cause serious illness or death, they may occur without presenting any symptoms, making them difficult to detect.

If you or someone you love was exposed to infection during an open-heart surgery using the Stockert 3T system, you may be able to file a legal claim.