A man is suing LivaNova PLC, known for their Sorin 3T Heater-Cooler System, after he allegedly contracted a bacterial infection from open heart surgery during his hospital stay at Greenville Health, located in South Carolina.

The Sorin 3T Heater-Cooler System was used to regulate his body temperature during the surgical procedure. The heater-cooler system is particularly important to open-heart surgeries as it helps keep helps keep the organs of the body at a safe temperature.

Plaintiff Edward R. files this complaint alleging defendant LivaNova PLC failed to manufacture the Sorin 3T System in a way that would prevent it from becoming colonized with bacteria. Edward believes negligent design and manufacture on LivaNova’s part led to his infection from open heart surgery.

Edward underwent the open-heart surgery or aortic valve replacement at the Greenville Health System Hospital when he contracted the NTM infection in January 2014. The bacterial infection he contracted is nontuberculous mycobacterium, or NTM.

Following the open-heart surgery and after being formerly discharged from the hospital, in April, Edward says he began showing signs of a “red rash and bubbling” in the area close to his incision site.

Moreover, he began to display signs of weakness and fever, and he developed pneumonia. Once admitted again into the hospital, Edward was placed on antibiotics and had to undergo sternal debridement for the infection from open heart surgery.

According to the plaintiff, “the wound cultured out was mycobacteria … [he] was discharged home … was scheduled for home health care, as well as regular treatment by an infectious disease physician …”

According to the Centers for Disease Control and Prevention, or CDC, “more than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year… [and] approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections,” the federal agency states.

The Sorin 3T Heater-Cooler System works by keeping water at a specific temperature and using it to either raise or lower a patient’s body temperature as required.

The inside of the Sorin 3T can become contaminated with mycobacteria. These mycobacteria may be blown out of the machine through its exhaust vent and into the air in the operating room. Such contamination can lead to infection from open heart surgery as suffered by the plaintiff, Edward contends.

Specifically, “when the water used in the reservoir of the device contains even trace levels of NTM, the bacteria colonizes, and patients are exposed to the bacteria that are aerosolized through the device’s exhaust vent,” the claim alleges.

Moreover, airborne contraction of the bacterial infection, or NTM, from heater-cooler systems was deemed to jeopardize patient safety throughout Europe in 2011.

The Federal Drug Administration administered a “Safety Communication” between January 2010 and August 2015 stating that it had received 32 reports of patient infections associated with the Sorin 3T. Eight reported infections were in the U.S., and the other 24 were in western Europe.

Additionally, the CDC issued forewarning and an “Interim Practical Guidance” notice to healthcare facilities and health departments, aiming to increase awareness of the link between the heater-cooler system and contraction of the NTM infection.

The Sorin 3T System Lawsuit is Case Number. 6:17-cv-01060-BHH, in the U.S. District Court for the District of South Carolina, Greenville Division.