A South Carolina woman has filed a lawsuit against Sorin Group claiming that as a result of the use of their Sorin 3T system which provides temperature controlled water to heart surgery heat exchanger devices, she was exposed to a bacterial infection.

Plaintiff Felicia J. underwent a cardiopulmonary bypass procedure in Greenville, South Carolina, during which Sorin’s 3T Heater-Cooler System was utilized.

She claims she was exposed to nontuberculosis mycobacteria as a result of the Sorin 3T system.

During Felicia’s procedure, the Sorin 3T Heater-Cooler System was used to control the temperature of the heart surgery heat exchanger devices used in her surgery.

When she was discharged from the hospital, her surgical incisions were intact and healing well. However, about two months later, she began to notice sternal dehiscence and drainage from the sternal wound. She also experienced severe pain around the wound area.

In May of that year, two months after her heart surgery, Felicia was readmitted to the hospital.

She was forced to undergo a series of procedures including sternal debridement and washout procedures, a muscle flap procedure, wound vac therapy and placement of a PICC line.

When physicians tested the wound site, they found evidence of a bacterial infection. Felicia believes this infection came as a result of the Sorin 3T Heater-Cooler system provided exposing her heart surgery heat exchanger devices to bacteria.

Felicia holds Sorin Group completely responsible for the damages she has suffered.

Heart Surgery Heat Exchanger Devices

The 3T Heater-Cooler System is a device used to keep patients warm during open-heart surgery.

The Sorin 3T system works by providing temperature controlled water to heart surgery heat exchanger devices. These heart surgery heat exchanger devices can include cardio-pulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets.

Heart surgery heat exchanger devices must be temperature controlled so that they can warm or cool a patient during long cardio-pulmonary bypass procedures that can last six hours or longer.

It is important to keep the patient’s body temperature under control during open-heart surgery because it improves patient outcomes.

However, the trouble with these types of systems, according to the Food and Drug Administration, is that the water that heats or cools the heart surgery heat exchanger devices may carry bacteria to the patient’s body during the procedure.

The water from inside the system is not supposed to come in contact with the patient, but the FDA issued a warning in June 2016 stating that the water inside the system can aerosolize or find its way into other parts of the device.

Water can then exit the device through its exhaust vent and into the air of the operating room. This potentially carries contaminants and bacteria to any open surgical sites on the patient’s body.

Felicia is bringing claims of negligence, strict products liability, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violation of the South Carolina unfair trade practices act.

She claims that she suffered physical and emotional pain, permanent impairment and scarring, medical bills and expenses, loss of earnings and earning capacity and loss of enjoyment of life among other things.

The Heart Surgery Heat Exchanger Devices Lawsuit is Case No. 6:16-cv-03130 in the U.S. District Court for the District of South Carolina, Greenville Division.