In response to her father’s death, a woman filed a lawsuit against the manufacturers of the Sorin 3T Heater-Cooler system which was used during her father’s heart surgery at Greenville Health System Hospital (GHS) in South Carolina.

Plaintiff Tina D. states that her father underwent a heart surgery bypass procedure on April 15, 2014 and during his heart surgery procedure, the Sorin 3T Heater-Cooler system was utilized, and the medical device caused him to be exposed to nontuberculosis mycobacteria.

Within a year, Tina’s father died due to effects from the mycobacterium abscessus infection.

Heart Surgery and the Sorin 3T Cardiac Heater-Cooler

The Sorin 3T Heater-Cooler system is a medical device used during heart surgery to warm or cool a patient during surgeries that last six hours or less.

The device aims to control the body temperature of the patient while undergoing surgery, in an attempt to improve patient outcomes.

Just two months after Tina’s dad had heart surgery at GHS, the hospital made a public announcement stating that about 14 patients had tested positive for a rare non-tuberculosis mycobacteria infection, known as mycobacterium abscessus.

The patients were exposed to the bacteria during the open-heart surgeries they underwent at GHS. The next month, GHS stated that 15 patients tested positive and four had died.

Following the second announcement, GHS stated that the hospital sent letters out to approximately 180 patients who underwent heart surgery and on whom “specific cardiopulmonary surgical equipment had been used.”

Tina’s father received one of these letters, listing him as being potentially exposed to the mycobacterium abcessus bacteria.

Because it is so rare, this type of mycobacterium infection is typically not tested for unless a physician has specifically been made aware that a patient has been exposed to this particular type of mycobacterium.

For some, treatments of this bacterial infection are successful and for others, it can ultimately lead to their death.

In July 2015, the FDA issued a recall of the Sorin 3T System that was used on Tina’s father during his heart surgery. This recall was a result of the “potential colonization of organisms, including mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed as per instructions for use.”

The lawsuit states that “Defendants’ Sorin 3T System has high injury and complication rates, fails to perform as intended, requires patients to undergo additional operations, and has caused severe and sometimes irreversible injuries, conditions, and damages to a significant number of patients, including the Plaintiff.”

Tina has brought forth a number of counts against the manufacturer including 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, survival and wrongful death.

She is seeking punitive damages, actual damages for physical pain and suffering, emotional pain and suffering, permanent impairment, medical bills and expenses, loss of earnings and earning capacity, loss of enjoyment of life, pre-and post-judgment interest, statutory and discretionary costs and any additional relief deemed proper by the Court.

The Sorin 3T Heater Cooler Heart Surgery Lawsuit is Case No. 6:16-cv-03131, in the U.S. District Court for the District of South Carolina, Greenville Division.