Patients who suffer from heart surgery bacterial infection have begun to file heater-cooler lawsuits against the manufacturer of a surgical temperature control device.

Heater-cooler units, like the Stockert 3T Heater-Cooler System manufactured by LivaNova PLC (formerly Sorin Group Deutschland), are one of the most commonly used devices for controlling patients’ body temperature during surgery. However, the device has been linked to the spread of heart surgery bacterial infection, specifically of nontuberculous mycobacteria (NTM), blamed for causing serious illness and even death.

Overview of Heart Surgery Bacterial Infection

Heater-cooler lawsuits allege that a defect in the Stockert 3T led to bacterial infection in open heart surgery patients. The device is used to regulate body temperature during heart and lung surgical procedures and to improve patient outcomes.

Safety warnings have been issued both by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) alleging that the device exposes patients to nontuberculous mycobacteria (NTM) infections during surgery.

The CDC, in 2015, announced that it had “identified a need for increased vigilance for NTM infections by health departments, health care facilities and individual health care providers.”

An FDA announcement also addressed concerns about heater-cooler devices and NTM infections. The FDA advised patients to look for signs of potential patient infection even after surgical procedures. This is because of the long delay possible between exposure and discovery of heart surgery bacterial infection.

To lower a patient’s risk for severe injuries and complications from NTM infections, early diagnosis and treatment is crucial. Untreated heart surgery bacterial infection can be fatal.

In the FDA’s announcement, they stated that “through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.”

Exposure and Symptoms of NTM Infections

The heater-cooler device works by providing temperature-controlled water to warming/cooling blankets through closed circuits. During normal operation, the water in the machine does not come into direct contact with the patient. The potential for a patient to become contaminated by NTM bacteria comes when the bacteria is transmitted through the air, like through mist or air particulates. Water from contaminated areas within the system may be forced out through the tank’s exhaust vent and into the air of the operating room.

A nontuberculous mycobacteria (NTM) infection can cause severe lung disease. A person infected with the bacteria may suffer adverse effects and complications, particularly if they have an impaired immune system. Permanent damage to a person’s lungs can also occur in severe cases of a heart surgery bacterial infection.

Following exposure to the bacteria, heart surgery bacterial infection can take months or even years to show symptoms. The symptoms of the infection progress slowly, and often, because symptoms of an NTM infection can be like those of other lung conditions, the infection can be misdiagnosed, if caught at all.

Some symptoms of an NTM infection may include fatigue, difficulty breathing, loss of energy, fever, nausea, night sweats, abdominal pain, persistent cough or cough with blood, and a lack of appetite.