A widower from South Carolina says a defective surgical device was the cause of an infection after heart surgery that ultimately took his wife’s life.

Plaintiff Melvin M. says his late wife Ella Mae developed a mycobacteria infection after heart surgery.

He is now bringing a claim against Sorin Group Deutschland and its U.S. counterpart, the manufacturers of the Sorin 3T Heater-Cooler System used during Ella Mae’s surgery.

Melvin says Ella Mae underwent cardiac bypass surgery in September 2013, during which a Sorin 3T system was used to control the temperature of her blood.

After the surgery, she showed some signs of a possible infection in her sternal wound.

The wound was cleaned, and Ella Mae was given a course of antibiotics. Melvin says the rest of her recovery was uncomplicated, and she was discharged in October 2013.

Then in March 2014, while Ella Mae was being treated for a pseudoaneurysm of the aorta, her doctors noticed signs of a possible infection. A sample of tissue tested positive for mycobacterium chelonaea-abscessus.

After repair of her aorta and treatment for the mycobacterium infection, Ella Mae was discharged and placed under home hospice care. Melvin says she finally died from the infection in June 2014.

Melvin now alleges the Sorin 3T system was the cause of Ella Mae’s infection after heart surgery, and ultimately of her death.

Plaintiff: Manufacturer Knew About Risk of Infection After Heart Surgery

According to this Sorin wrongful death lawsuit, the Sorin 3T system is used to provide temperature-controlled water to heat-exchanging devices that are used to keep a patient warm during cardiac surgery.

M. abscessus, the bacteria that was the source of Ella Mae’s deadly infection, is a slow-growing bacterium. It can take weeks or even years to develop into a mycobacterium infection, the Sorin lawsuit says.

Melvin says that Ella Mae’s infection was not the only one reported at Greenville Health System Hospital at around that time.

In June 2014, the hospital announced that about 14 patients had tested positive for a similar mycobacteria infection. Most of these patients had developed their infection after heart surgery, the hospital said.

After an investigation of the outbreak, the South Carolina Department of Health and Environmental Control mandated a set of measures to implemented immediately at the hospital, specifically regarding use of the Sorin 3T system.

Then in July 2015, the FDA ordered a recall of the Sorin 3T. According to the FDA, the Sorin 3T can allow mycobacteria to colonize inside the machine if proper care isn’t taken to maintain and disinfect the system.

Melvin alleges the defendants were aware of the risk of infection associated with the Sorin 3T system yet failed to take adequate steps to address it.

He claims the defendants failed to provide adequate warnings, instructions and safety information both before and after marketing the Sorin 3T system.

Had the defendants provided adequate warnings about the Sorin 3T, neither Ella Mae nor her treating physicians would have chosen to use the system during Ella Mae’s surgery.

The Sorin 3T Wrongful Death Lawsuit is Case No. 6:16-cv-03128 in the U.S. District Court for the District of South Carolina.