A couple from South Carolina alleges the husband developed a serious infection after heart bypass surgery because of contamination in a surgical heater-cooler system.

The device in question was allegedly the Sorin 3T System, with certain models reportedly contaminated with the deadly nontuberculous mycobacteria M. chimaera.

Plaintiffs Joseph B. and Brenda B. jointly filed this claim, alleging the potentially deadly infection manifested years after surgery.

According to the Sorin cardiac heater cooler lawsuit, Joseph underwent a coronary artery bypass surgery on Sept. 18, 2013 that had reportedly utilized the Sorin 3T System. This device was reportedly used to help control his body temperature while he was under anesthesia.

Joseph says neither he nor his physicians noticed any signs near the surgical site that indicated a bacterial infection. In fact, the lawsuit points out that the surgical area appeared to be healing well many months after the surgery. Joseph says his physicians suspected something was wrong on Dec. 31, 2015, when he suffered a fall at home and experienced increased swelling around some fractured ribs.

When Joseph was admitted to the hospital, doctors allegedly noted a number of cardiac complications including atrial dilation and increased right atrial pressure. At this time, Joseph says he was not tested for the M. chimaera bacteria and was not tested until he was readmitted for hospitalization on Nov. 10, 2015 due to having a boil-like lesion on the incision site.

After several diagnostic tests, Joseph claims, he was diagnosed with M. chimaera infection after heart bypass surgery and had undergone six weeks of antibiotic treatment with various antibiotics.

Even after he underwent this rigorous treatment, medical tests as recent as July 2016 show that Joseph is continuing to suffer from an infection after heart bypass surgery from years earlier, the couple claims.

Overview of Sorin 3T Cardiac Heater Cooler Complications

The Sorin 3T System is a cardiac heater cooler device that is used to help maintain proper temperature in blood and internal organs during bypass surgeries. The device consists of two temperature controlled water tanks. The water is used to exchange heat through other medical devices, and it does not make direct contact with the patient.

Scientists believe that M. chimaera bacteria may be getting released into the air though the system’s exhaust vent, putting the patient at serious risk for infection. The FDA warned about this issue in October 2015, stating that the federal agency received 32 Medical Device Reports indicated patients developed a serious infection after undergoing a procedure using heater cooler devices.

It was not until a later warning in June 2016, that the FDA identified the Sorin 3T System manufactured by LivaNovaPLC as the heater cooler device associated with the M. chimaera infections. It is believed the contamination may have occurred during the manufacturing process in a plant in Germany, where bacteria was discovered when the facility underwent testing in September 2014.

The FDA updated its information regarding this concern on October 2018, providing a list of recommendations to healthcare professionals to prevent the spread of infection after heart bypass surgery.

This Sorin Cardiac Heater-Cooler Lawsuit is Case No. 6:18-cv-03117-DCC, in the U.S. District Court of South Carolina, Greenville Division.