A woman has filed a lawsuit against LivaNova and Sorin Group alleging the Sorin 3T Heater- Cooler System that was used on her husband during his surgery ultimately ended in his death.

Plaintiff Lori W. States in her Sorin 3T Heater-Cooler lawsuit that on March 27, 2014, her husband underwent a bypass procedure at Greenville Health System Hospital (GHS) in South Carolina where a Sorin 3T Ruler-Cooler System was used.

She claims this exposed her husband to non-tuberculosis mycobacteria.

What is the Sorin 3T Heater-Cooler?

The Sorin 3T Heater-Cooler is a medical device that is used during cardio-pulmonary bypass procedures that last six or less hours in duration.

It provides temperature controlled water to heat exchanger devices in the operating room.

Such devices are cardio-pulmonary bypass heat exchangers, thermal regulating blankets and cardioplegia heat exchangers.

These devices are used to warm or cool a patient during the surgery so that the patient’s body temperature is maintained at an ideal level, improving surgical outcomes.

Complications Arising from the Use of the Sorin 3T Heater-Cooler

In June 2014, GHS publicly announced that around 14 of its patients tested positive for a rare infection, known as mycobacterium abcessus, and that the majority of these patients were exposed to this bacteria during the open-heart surgeries they underwent at the hospital.

Three of these infections led to deaths at the time the announcement was made.

The following month, GHS confirmed 15 actual cases of mycobacterium infections, and a total of four patients had died as a result.

After the second announcement, the hospital stated it sent out about 180 letters to patients “on whom specific cardiopulmonary surgical equipment had been used.”

The plaintiff’s husband allegedly received one of these letters.

Non-tuberculosis mycobacterium infections are sometimes able to be treated with a prolonged course of antibiotics, infected tissue removal, and other procedures, but sometimes these treatments are unsuccessful and patients ultimately die due to the infection.

In July 2015, a Class II recall of the Sorin 3T System was issued by the FDA due to the “potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per instructions for use,” the Sorin 3T Cooler-Heater lawsuit states.

In December 2015, the FDA also sent a warning letter to the device manufacturers regarding the company’s questionable manufacturing practices, the lawsuit states.

Lori has brought forth a number of counts against the device manufacturers, including negligence, strict products liability, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violations of the South Carolina Unfair Trade Practices Act, survival, loss of consortium (spousal companionship) and wrongful death.

She is seeking punitive damages and actual damages including those linked to physical and emotional pain, medical bills and expenses, loss of earnings and loss of enjoyment of life, among other damages.

Filing a Sorin 3T Heater-Cooler Lawsuit

If you or a loved one developed a non-tuberculosis mycobacteria infection following a heart surgery which used the Sorin 3T Heater-Cooler medical device, you may be entitled to legal compensation as a result.

An experienced attorney can review your situation in a complementary case review and can help you decide if filing a Sorin 3T Heater-Cooler lawsuit is right for you.

The Sorin 3T Heater-Cooler Lawsuit is Case No. 6:16-cv-02286 in the U.S. District Court for the District of South Carolina, Greenville Division.