In a surgical infection lawsuit, a patient’s family claims that LivaNova’s Sorin 3T cardiac heater-cooler caused a fatal infection.

Plaintiff James J. claims that the late Kevin J.’s death was a result of an infection he suffered as a result of the use of the Sorin 3T cardiac heater-cooler during a surgery.

James claims that Kevin was hospitalized on Nov. 2, 2011, for bioprosthetic aortic stenosis, a heart condition that requires the use of prosthetic tissue values to repair a patient’s aortic valve. Allegedly, the Sorin 3T cardiac heater-cooler was used during the surgery and left him with an infection that eventually led to his death. This led to the family filing a surgical infection lawsuit. 

The surgical infection lawsuit states that the Sorin 3T cardiac heater-cooler is a medical device made by LivaNova that is used to keep a patient’s body temperature regulated during open heart surgery. Allegedly, the Sorin 3T cardiac heater-cooler can introduce bacteria into a patient’s body in an otherwise sterile surgical environment.

James reports that the device regulates blood temperature in a patient by “circulating water through tubes into a heat exchanger where blood is pumped into separate chambers during surgery.” Allegedly, the tanks are often not sufficiently cleaned, and bacteria in the tanks can exit in the form of aerosolized water, into the air of the operating room.

James alleges this contamination is made possible because the device’s manufacturer provided American medical professionals with insufficient cleaning instructions, so in many cases in which the device was used, it was not sterile when used in surgery.

Allegedly, in 2011, the FDA visited the LivaNova’s manufacturing plant in Germany, where the cardiac heater-cooler is made, and determined that the device “harbored dangerous bacteria and that [the company] had failed to make a proper risk assessment for cleaning the devices to avoid bacterial infections in patients exposed in the operating room.” The FDA then allegedly recommended that the company revise its cleaning procedures.

James then goes on to state that in January 2014, the company received reports of patients suffering infection after surgeries in which the Sorin 3T cardiac heater-cooler was used. The company then reportedly created a task force to investigate the infection risk in May 2014, finding that there was a link between insufficient cleaning of the device and patients developing an infection. 

James notes that in July 2015, the FDA issued a recall of the Sorin 3T heater-cooler device, but argues there were years in the interim period in which the devices were used in surgeries, possibly injuring patients like Kevin. Further evidence supporting the claim of a connection between the device and bacterial infections was allegedly published in 2015, 2016, and 2017.

James’s surgical infection lawsuit claims that after Kevin’s surgery in 2011, he was hospitalized multiple times with an infection in his aorta, which manifested in the form of a pus-filled root abscess. Allegedly, the bacteria found in Kevin’s abscess was the type of bacteria associated with the Sorin 3T Heater-Cooler.

Kevin passed away in 2015, allegedly as a result of complications associated with his aortic infection. James states that in 2016, he received a letter from the hospital in which Kevin received care, that notified him of the likely connection between the Sorin 3T Cardiac Heater-Cooler and bacterial infection like Kevin’s.

James claims that LivaNova knowingly distributed the Sorin 3T Heater-Coolers and allowed the devices to be used while knowing that they caused deadly infections, and claims that the company’s actions lead to Kevin’s death.

The Sorin 3T Cardiac Heater-Cooler Surgical Infection Lawsuit is Case No. 5:18-cv-00556-GTS-ATB, in the U.S. District Court for the Northern District of New York.