A Maryland couple has filed a heart surgery infection lawsuit against LivaNova PLC, manufacturers of the popular Sorin Stockert 3T heater cooler system, alleging that the device caused the development of a Mycobacterium chimaera (M. chimaera) infection following surgery.

Plaintiffs Michael M. and Carol M. file the heart surgery infection lawsuit in Maryland federal court. The lawsuit was filed on Feb. 2, 2018.

According to the heart surgery infection lawsuit, Michael underwent a triple coronary artery bypass graft and aortic valve replacement surgery at Christiana Hospital in Newark, Del. The heater cooler device was used during the surgery to provide proper circulation and body temperature as Michael underwent the procedure, the lawsuit states.

However, the couple says that in December 2016, Michael began to experience kidney failure, night sweats, fatigue, unexplained fevers, and weight loss. His body yielded a positive result for infection by M. chimaera in April 2017.

The heart surgery infection lawsuit was filed on multiple counts including negligence, manufacturing defect, warning defect, breach of implied warranty, and negligent misrepresentation.

The couple demands a jury trial.

Overview: Heart Surgery Infection Lawsuit

The Stockert 3T heater cooler device was designed to regulate and maintain a patient’s body temperature during invasive surgical procedures. The 3T system works to keep safe a patient’s vital organs and regulates the body’s temperature to maintain proper circulation of the patient’s blood and provide nutrients to the body.

The Stockert 3T system works by storing water in a tank. The water temperature can be regulated as needed, thereby cooling or heating up a patient’s body temperature.

However, there have been several concerns stemming from the use of a 3T heater cooler device. M. chimaera bacteria have been found inside some 3T heater cooler systems. As the device becomes contaminated, bacteria can aerosolize and be forced out through the device’s exhaust vent, causing patient infection.

According to the heart surgery infection lawsuit, on June 1, 2016, the U.S. Food and Drug Administration (FDA) issued a Safety Communication to healthcare providers about the non-tuberculosis infection (NTM) associated with the Stockert 3T system.

The bacterium at issue is a subspecies of NTM known as M. Chimaera. Although it poses no risk and rarely causes illness in the environment, it poses a unique risk to patients who become directly exposed to it during invasive heart procedures.

According to the lawsuit, an M. Chimaera infection can take anywhere from several weeks to six years before the infection begins to settle in the body. Symptoms of the infection include: night sweats, joint and muscle pain, unexplained weight loss, fatigue, persistent fever, and pain.

CDC Warnings

According to the Centers for Disease Control and Prevention (CDC), “The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer’s instructions for use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports for the United States and overseas.”

According to the CDC, with over 250,000 cardiopulmonary bypass procedures performed in the United States every year, “the Stockert 3T heater-cooler devices represent approximately 60% of the U.S. market.”

The Heart Surgery Infection Lawsuit is Case No. 1:18-cv-00480-ELH, in the U.S. District Court for the District of Maryland, Baltimore Division.