Patients and medical community are worried over the dangers of the cardiac heater-cooler device known as the Stockert 3T Heater-Cooler System, due to reports of post operation bacterial infections.

Patients allege the device caused them to become infected by rare mycobacterium chimaera bacterial cells, which led a potentially fatal condition.

Manufactured by LivaNova PLC in Germany, the dangers of the cardiac heater-cooler in question caught the attention of the FDA in January 2014 as well as attention of the Center of Disease Control.

A year later in October 2015, the FDA issued a public safety warning regarding the dangers of cardiac heater-cooler units after receiving 32 reports of bacterial infection.

The Stockert 3T Heater-Cooler system consist of tanks filled with temperature controlled water, which work to regulate the patient’s body temperature during an operation.

Even though the water never makes direct contact with the patient, the FDA warned that it is possible for “contaminated water to enter other parts of the device and aerosolize.”

This means that bacteria can becomes airborne through the device’s exhaust vent, which can allow the bacterial cells to enter the environment and land in the patient’s chest cavity during the operation.

Overview of the Dangers of Cardiac Heater-Cooler

These cardiac heater-coolers are used for approximately 250,000 open heart surgeries per year, with nearly 60% of the machines manufactured in the same manufacturing plant in Germany.

The cardiac heater-coolers manufactured in this plant have been allegedly linked to deadly bacterial infections since 2006. According to the CDC, patients who experience the following symptoms may be at risk for the deadly dangers of cardiac heater-cooler devices:

• Night sweats
• Muscle aches
• Weight loss
• Fatigue
• Unexplained fever

The FDA released a warning in June 2016, with the agency recognizing that these dangerous bacterial infections were linked to the Stockert 3T Heater-Cooler system.

Several months later, the FDA recommending that health officials take preventative measures against the dangers of the cardiac heater-cooler. Among the recommended preventative measures included using new accessories and tubing in the device, and pointing the exhaust fan away from the patient.

In addition, the FDA also warned that patients who underwent cardiac transplant surgery may be at an increased risk for infection.

Approximately 28 cases of cardiac heater-cooler infection have been identified in United States, along with other reports in Europe, making the dangers of cardiac heater-cooler prominent concerns for the medical community.

Even though the dangers of cardiac heater-cooler devices are potentially fatal to patients, LivaNova PLC allegedly failed to disclose this information to patients.

A cardiac heater-cooler class action lawsuit was filed in February 2016 by Pennsylvania patients who had reportedly suffered bacterial infections after undergoing open heart surgeries.