A couple who claims the husband was exposed to potentially deadly infection during open-heart surgery, known as nontuberculosis mycobacteria, has filed a lawsuit against the maker of the the Sorin 3T Cardiac Heater-Cooler device, seeking punitive and actual damages.

Plaintiffs James and Kaye T. of South Carolina filed the lawsuit in federal court against Sorin Group, the company that manufactures the heater-cooler device used in James’ surgery.

In March 2014, James underwent a coronary artery bypass grafting procedure at Greenville Health System Hospital (GHS) during which the Sorin 3T Heater-Cooler System was utilized, exposing him to nontuberculosis mycobacteria, the lawsuit states.

The couple claims that about four months after his heart surgery, James began to notice pain, swelling, and tenderness, and a “lump” that had developed at his incision site.  He also began to experience fevers and increasing weakness.

James was re-admitted to GHS in August 2014, where he underwent procedures to treat his condition. After a repeat I&D procedure in addition to a muscle flap and wound vac placement, it was revealed that James had contracted the nontuberculosis mycobacteria infection.

What is the Sorin 3T Cardiac Heater-Cooler System?

The Sorin 3T System is intended to provide temperature controlled water to heat exchanger devices  such as cardio-pulmonary bypass heat exchangers, to warm or cool a patient during heart surgery lasting six hours or less.

On July 15, 2015, the FDA announced a recall of the Sorin 3T System due to infection risks. In October of the same year, the FDA issued a safety communication indicating that a large number of adverse event reports have been received involving problems with surgical heating/cooling device.

GHS Announce Patients Positive for Nontuberculosis Mycobacteria

On June 20, 2014, Greenville Health System Hospital publically announced that approximately 14 patients had tested positive for a rare nontuberculosis mycobacteria infection, known as mycobacterium abcessus.

This type of infection is a “slow growing bacterium” that can take anywhere from weeks to years before it manifests into a nontuberculosis mycobacteria infection.

The majority of these patients were exposed to the bacterium during open heart surgeries.

At that time, GHS indicated that there had been three deaths resulting from the same infection. About six days later, the hospital released a second statement indicating that there were 15 confirmed cases of of patients with nontuberculosis mycobacteria.  Shortly after, GHS confirmed that the patient death toll had increased to four.

Investigations by the South Carolina Department of Health and Enviromental Control in an effort to determine the cause for the mycobacterium abcessus outbreak at GHS.

On July 21, 2014, prior to the recall on the Sorin 3T System, the SC DHEC released a statement that outlined specific measures that needed to be immediately implemented at GHS as it related to the Sorin 3T System.

Symptoms of Nontuberculosis Mycobacteria

Tissue that has been infected with mycobacterium abcessus usually presents as “red, warm, tender to the touch, swollen, and/or painful” and infected areas can appear as “boils.”

Additional signs and symptoms of the infection can include:

• Fever
• Chills
• Muscle aches
• General feeling of illness

While death is certainly a risk of nontuberculosis mycobacteria infection, there are treatments available. Those include draining collections of pus or removing the infected tissue coupled with rigorous administration of a series of antibiotics for prolonged periods of time, depending on the degree of the patient’s infection and response.

If you or somebody you know has been diagnosed with a nontuberculosis mycobacteria infection following heart surgery, you should contact an experienced dangerous medical device attorney for a free case consultation.

The Sorin 3T Cardiac Heater-Cooler Infection Lawsuit is Case No. 6:16-cv-03129 in the U.S. District Court for the District of South Caroline, Greenville Division.