LivaNova PLC faces a new Sorin heater cooler lawsuit from a grieving woman alleging her loved one had developed a serious bacterial infection soon after their open heart surgery.

The Sorin heater cooler lawsuit was filed by a woman from Alaska, who alleges her loved one had developed a M. chimaera bacterial infection due to the cardiac heater cooler device being contaminated.

Plaintiff Anna U. filed this Sorin heater cooler lawsuit on behalf of Ray A., who had been living in California at the time of his open heart surgery and developed the M. chimaera bacterial infection.

As with many other patients, the Sorin Heater Cooler System was used during Ray’s open heart surgery to help maintain a healthy body temperature while he was under anesthetic.

The Sorin Heater Cooler System consists of two temperature controlled water tanks which do not make direct contact with the patient. The device helps to ensure the patient’s body temperature does not lower to dangerous levels.

This temperature control method is supposed to help encourage healing, with these devices used in approximately 250,000 open heart surgeries per year. However, the Sorin Heater Cooler System has been recently linked with potentially fatal M. chimaera bacterial infections.

According to the Sorin heater cooler lawsuit, Ray had undergone an aortic valve replacement and mitral valve repair on April 8, 2014 with LivaNova’s heater cooler device used during the procedure. Like many other patients who reportedly developed M. chimaera bacterial infections, Ray allegedly did not begin to exhibit symptoms of infection until several months after the surgery.

Ray had reportedly begun exhibiting symptoms of the M. chimaera bacteria infection in November 2016 including severe fever and weight loss, and his condition progressively worsened until he was hospitalized on Feb. 13, 2017.

Anna says his doctors suspected he was suffering from the M. chimaera infection, and was put on antibiotic treatment several days later. The M. chimaera infection was eventually confirmed on March 1, 2017, with Ray eventually succumbing to the disease on March 7, 2017.

Anna later filed this Sorin heater cooler lawsuit on Ray’s behalf, alleging LivaNova failed to prevent their device from becoming contaminated with the M. chimaera bacteria.

Overview of Sorin Heater Cooler Complications

According to the FDA and CDC, models of the Sorin Heater Cooler System manufactured before September 2014 may have been contaminated with the M. chimaera bacteria. In September 2014, a bacterial contamination was found in the German facility where the Sorin Heater Cooler System is manufactured. The contamination was reportedly resolved in July 2015 when the manufacturing plant was retested.

The FDA issued the first public warning in October 2015, with the agency stating it had received 32 Medical Device Reports (MDR) from patients who had allegedly developed a cardiac heater cooler infection.

M. chimaera bacterial infections linked to the Sorin Heater Cooler System have been reported in Iowa, Michigan and Pennsylvania from early 2011 to present time. According to the CDC, there have been a total of 28 confirmed M. chimaera infections and at least 12 patients may have died from the infection.

This Sorin Heater Cooler Lawsuit is Case 2:18-cv-06884-SJO-AFM, in the U.S. District Court of Central California.