A popular medical device used to regulate the temperatures of patients while they are undergoing surgery has been connected with cardiac surgery infection, according to a report by the Food and Drug Administration (FDA). Certain cardiac heater cooler devices have been linked to the spread of M. chimaera, a type of cardiac surgery infection.

What is a Heater-Cooler Device?

Heater cooler devices are designed to help patients who are undergoing cardiothoracic surgeries maintain their body temperature and recover quickly. According to the FDA, these devices contain water that can heat or cool other devices, like warming and cooling blankets, that provide support to a patient during surgery.

“Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits,” notes the FDA report.

Although water does not come into contact with patients, the FDA reports that there is a possibility that the water can aerosolize and, if it is contaminated in some way, bacteria can be transmitted through the air through the exhaust vent in certain models of heater cooler devices.

A surgery room is supposed to be clean and free of contaminants, however, with certain models of heater-cooler devices, this may not be the case. Some models have been associated with the transmission of a certain type of bacteria that causes Nontuberculous Mycobacteria (NTM) infections.

“NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in some patients,” the FDA reports.

The Stockert 3T heater cooler system is a medical device manufactured by Italian company, Liva Nova. They are widely used during cardiac surgery in the United States.

Not that long ago, the FDA put out a warning about this particular model of heater-cooler device. About sixty percent of cardiac surgeries in America are performed with the help of some type of heater-cooler device.

The Center for Disease Control (CDC) reports that they may have found bacteria in certain devices putting patients at risk for cardiac surgery infection.  The CDC also found that bacteria in certain heater cooler devices match the cardiac surgery infection found in some patients.

Neither the CDC nor the FDA has been able to undoubtedly connect any deaths with an NTM cardiac surgery infection, however, it is suspected that several individuals have died as a result of such an infection.

Both the CDC and the FDA encourage those who have undergone cardiac surgery with the aid of a heater-cooler device to be on the lookout for certain symptoms of infection. These include night sweats, weight loss, fever, loss of appetite and loss of energy.

If you suspect that you or someone you love may be suffering from a NTM cardiac surgery infection, you may benefit from speaking to an experienced attorney.