A new cardiac surgery infection lawsuit blames contaminated surgical equipment for a Texas woman’s death.

Plaintiff James H. is bringing this claim on his own behalf and that of the estate of the late Stephanie H. James alleges Stephanie’s death can be traced to the use of a Sorin 3T heater-cooler system during her heart surgery.

James says contamination in the Sorin 3T caused a slow-growing infection that ultimately took Stephanie’s life.

According to this cardiac surgery infection lawsuit, Stephanie went in for open heart surgery in February 2015. Her temperature was kept under control during surgery through use of a Sorin 3T heater-cooler system, James alleges.

Then in March 2016, more than a year after Stephanie’s surgery, she went to the hospital complaining of weakness, shortness of breath, and bilateral leg pain.

She presented with “severe metabolic acidosis and rhabdomyolysis,” James says. Her medical records showed she had been in and out of the hospital in the preceding months with complaints of “exertional dyspnea, fatigue and rash.”

James says Stephanie was diagnosed with an infection. She died of septic shock on March 9, 2016.

Manufacturers Named in Cardiac Surgery Infection Lawsuit

James names as defendants medical device manufacturers LivaNova PLC, Sorin Group Deutschland GmbH, and Sorin Group USA, Inc. All three of these companies have been involved in the design, manufacture or marketing of the Sorin 3T heater-cooler system at issue in James’s claim.

The Sorin 3T system is a surgical device used to control a patient’s body temperature during open-heart surgery. It uses temperature-controlled water in a closed circuit to exchange heat in or out of the patient’s blood, so that the patient’s body maintains the optimum temperature.

This device was originally designed and manufactured by Munich-based Sorin. The Sorin 3T system became a product of Italian company LivaNova following a merger in October 2015.

The Sorin 3T has recently been the subject of a slew of negative publicity following revelations that connect the device to a rash of potentially deadly postsurgical infections.

According to a communication issued by the FDA, testing conducted in the manufacturer’s production facility in August 2014 revealed contamination with Mycobacterium chimaera.

Since then, the FDA says, it has received reports of patients in the U.S. who were infected with M. chimaera after undergoing surgery using a Sorin 3T system.

The agency also notes the results of a European study that suggest a direct link between infections in European patients and contamination in the Sorin 3T system.

Patients infected with M. chimaera may not show symptoms for months or even years after the infection begins to set in. Once symptoms appear, they tend to include fatigue, difficulty breathing, night sweats, and fever that can’t be otherwise explained.

James’s cardiac surgery infection lawsuit raises claims for defective manufacture and negligence. He seeks an award of damages, court costs and attorneys’ fees, all with pre- and post-judgment interest.

The Cardiac Surgery Infection Lawsuit is Case No. 1:17-cv-00078, in the U.S. District Court for the Western District of Texas.