A South Dakota couple alleges in a recent lawsuit that the Sorin3T Heater/Cooler System, used during surgery, has caused serious and life-threatening injuries.

The plaintiffs, Duane and Janna E., allege that the Sorin3T Heater/Cooler System led directly to ongoing pain and suffering, further surgeries, dramatic changes to their daily lives, and exorbitant medical expenses.

Duane E. underwent an aortic valve replacement surgery in June 2015. His surgery involved a Sorin3T Heater/Cooler System, used by the surgical team to cool and rewarm Duane’s blood as necessary for the procedure.

However, in the weeks and months post-surgery, the lawsuit alleges, Duane began to suffer from a variety of side effects that, by November 2016, had him readmitted to the hospital.

His health continued to worsen, according to the lawsuit, leading to a second aortic valve replacement a couple weeks later.

It was only during this surgery—months after the first—that the surgical team became aware that a massive infection of M. chimaera had compromised the aortic valve, leading to Duane’s consistent pain and suffering.

According to the lawsuit, the Sorin3T Heater/Cooler System introduced the M. chimaera infection into his body, causing serious complications that placed him at risk of death.

His injuries included hepatic dysfunction, acute kidney injury, coagulopathy, metabolic acidosis, and hyperglycemia.

Not only did the defects of the Sorin3T Heater/Cooler System cause injury and suffering, but also put Duane through rigorous medical treatment that prevents both Duane and his wife from continuing with their normal lives or jobs.

Indeed, the lawsuit alleges that the expenses from medical and hospital bills exceed $1,000,000.

The lawsuit was filed on multiple counts, including negligence, strict products liability, breach of express and implied warranties, negligent misrepresentation, misrepresentation by omission, and loss of consortium. The plaintiffs filed for both actual and punitive damages.

Sorin3T Heater/Cooler System Background

Cardiac heater/cooler devices like the Sorin3T Heater/Cooler System are used to control the temperatures of heating devices that adjust a patient’s temperature during a surgical procedure.

The Sorin3T Heater/Cooler System, manufactured by LivaNova PLC, is a device used during a variety of surgeries to warm and cool a patient’s blood and organs as necessary.

However, the CDC warns that during the manufacturing process, each of these devices may have been contaminated with a bacterial species of nontuberculous mycobacterium (NTM).

The Sorin3T Heater/Cooler System was recalled by the FDA in July 2015.

The recall was issued due to the “potential colonization of organisms, including Mycobacteria” in the Sorin3T Heater/Cooler System devices, the lawsuit notes, “if proper disinfection and maintenance is not performed per instructions for use.” Customers were instructed to follow newly issued instructions for use.

Filing a Lawsuit

If you or someone you love has suffered from a serious infection or other complications after undergoing a surgery performed with the use of a Sorin3T Heater/Cooler System or similar device, you may be able to file a lawsuit or join a class action lawsuit.

The Sorin3T Heater/Cooler System Lawsuit is Case No. 16-4175, in the U.S. District Court for the District of South Dakota, Southern Division.