Patients who developed a heater-cooler infection after a heart surgery may be eligible for compensation via a heater-cooler infection lawsuit.

Manufacturers of the Stocker 3T Heater-Cooler System have come under fire after numerous lawsuits were filed alleging that the device can cause a heater-cooler infection.

A heater-cooler device is used during heart surgeries to keep organs and blood at the proper temperature during the bypass process. The bypass process mimics the function of the heart and lungs to pump and oxygenate blood during surgery. This allows surgeons to operate on the heart without jeopardizing the blood flow of the patient.

However, patients can get very cold during the process, and a cardiac-heater cooler uses steam and warm water to heat the blood passing through the system. An estimated 250,000 surgeries a year involve a cardiac heater-cooler.

The water in the device does not come into contact with the patient’s blood. But lawsuits regarding the device have argued that contaminated water can pose a serious risk for patient health.

According to the U.S Food and Drug Administration (FDA), “there is potential for contaminated water to enter other parts of the device and aerosolize,” which means the bacteria can be transmitted in the air “through the device’s exhaust vent into the environment and to the patient.” If contaminated water breaches the sterile surgical field, the exposed organs can come into contact with dangerous bacteria, causing a heater-cooler infection.

Contamination with the device has been linked to the spreading of rare non-tuberculosis bacterial infections which can cause illness and death. Warnings about the possible contamination have been released by both the U.S Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The FDA estimated that 60 percent of devices used at hospitals have been linked to deadly infections and may have been in the United States since 2006.

Non-tuberculosis bacteria are a class of naturally-occurring organisms commonly found n water and soil. If the bacteria are not aerosolized, they pose little threat to human health. However, when the bacteria is aerosolized and comes into contact with exposed organs, it can result in a serious heater-cooler infection.

According to the American Lung Association, an NTM infection can be asymptomatic, but common symptoms include persistent cough, hemoptysis, fatigue, low grade fever, night sweats, and weight loss.

Over the past year, many hospitals have alerted their heart surgery patients of possible exposure and encouraged them to watch for symptoms of a possible heater-cooler infection. Although many hospitals have taken it upon themselves to warn their patients of the potential danger, such action is not required by any federal organization and no recall has been made.

The FDA is currently investigating the risks of cardiac heater-coolers but lawsuits argue that a recall needs to be issued to prevent further infections in heart surgery patients. In October 2015, the FDA issued its first communication on the device, stating that the agency had received 32 medical device reports concerning patients who had developed a heater-cooler infection.

In June 2016, the FDA stated that the development of a heater-cooler infection was linked to the contamination of the Stocker 3T heater-cooler. In October 2016, the FDA released a recommendations for health officials on how to contain and prevent the spread of infection.