It is estimated that half a million heart surgery patients may be at risk of contracting a potentially deadly infection due to a 3T Heater-Cooler device, which may have been contaminated during its manufacturing, government health officials warn.

LivaNova’s Stockert 3T Heater-Cooler device and other cardiac heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedures, according to the CDC.

What is a 3T Heater-Cooler Device?

Patients who undergo major surgical procedures, such as open-heart surgery, may require additional treatment while under anesthesia.

According to the U.S. Food and Drug Administration (FDA), heater-cooler devices are often used during major surgical procedures, including cardiothoracic surgeries, open-heart surgery and other medical procedures, to warm or cool a patient to produce effective medical care and improve patient outcomes.

Heater-cooler devices contain water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.

The Stockert 3T Heater-Cooler device, a heater-cooler system manufactured by the Sorin Group (a medical products group originally based in Italy and now known as LivaNova), is a heater-cooler device used in cardiac surgical procedures.

Infection Risk with a 3T Heater-Cooler Device

In addition to the CDC warning, the FDA issued an updated safety communication in October 2016, providing new information regarding the risk of Mycobacterium chimaera (M. chimaera) infections related to the use of the Stockert 3T heater-cooler device to heart surgery patients. M. chimaera is a type of nontuberculous mycobacterium (NTM), a naturally-occurring organism found in water and soil.

According to the FDA, symptoms associated with M. chimaera infections include:

• Fatigue
• Fever
• Pain, including muscle pain, joint pain and/or abdominal pain
• Redness, heat or pus at the surgical site
• Night sweats
• Weight loss
• Nausea
• Vomiting

Although the FDA believes M. chimaera infections are rare, they can be difficult to detect because those who have become infected may not develop symptoms or signs of an infection for months to years after initial exposure.

How a 3T Heater-Cooler Device Lawsuit Can Help

Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

People injured by a defective 3T heater-cooler device may be eligible to recover money for medical expenses, lost wages, pain and suffering. The families of those killed may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.

If you suffered an infection or other injury after undergoing surgery in which a LivaNova Stockert 3T Heater-Cooler device or other cardiac heater-cooler system was used, you should contact an experienced attorney immediately. You may be entitled to compensation by filing a lawsuit against the manufacturer.