A woman has filed an NTM infection lawsuit against LivaNova, the manufacturers of a cardiac heater-cooler device, alleging that the Sorin 3T Heater-Cooler System caused her to develop a Mycobacterium chimaera (M. chimaera) infection following the use of the device during surgery.

Plaintiff Kristine H. filed the NTM infection lawsuit in Kansas federal court, demanding jury trial. According to the NTM infection lawsuit, Kristine is a resident and citizen of the state of Kansas.

In the spring of 2017, Kristine says she experienced flu-like symptoms, including a fever. A blood culture tested positive for streptococcus sanguinis, and she was later diagnosed with aortic valve endocarditis after being admitted to Via Christi Medical Center in Wichita, Kan.

However, it was during a complex open heart surgery in which she was implanted with a permanent pacemaker at Kansas University Hospital in Kansas City, Kan.

It was there that the Sorin 3T Heater-Cooler System was used, the NTM infection lawsuit says. Although she was discharged on April 28, 2017, she went back to redo an aortic root replacement and coronary artery bypass, where the M. chimaera was cultured from her valve leaflets.

“As a direct and proximate result of Defendants’ negligent and liability producing conduct as described herein, Kristine … acquired an M. Chimaera infection, forcing her to undergo painful medical procedures and treatment, including but not limited to an additional open heart surgery, antibiotic therapy, routine echocardiograms and additional testing,” the complaint reads.

The NTM infection lawsuit was filed on multiple counts including negligence, manufacturing defect, warning defects, and loss of spousal consortium.

Overview: NTM Infection Lawsuit

A number of lawsuits have been filed against the makers of the Sorin 3T Heater-Cooler System. The lawsuits have been filed by patients that allege that they have suffered from contraction of bacterial infection. The infection is said to stem directly from the device. The Sorin 3T Heater-Cooler System is often used during invasive surgical procedures.

The purpose of the Stockert 3T device is to regulate and maintain a patient’s body temperature. It works to keep a patient safe and ensures the proper circulation of blood to vital organs, thereby continuing to nourish the body.

The system works by storing water in a tank. The water in the tank can be regulated to a specific temperature as required to heat or cool a patient’s body temperature as needed.

However, the tank can become contaminated. The risk for bacterial infection has become a grave concern. If the tank becomes contaminated, bacteria can aerosolize into the air of the operating room, potentially causing patient infection.

In fact, a Safety Communication was issued by the U.S. Food and Drug Administration (FDA) to healthcare providers about the risk for patient infection associated with the Stockert 3T System on June 1, 2016.

A subspecies of NTM known as M. chimaera is the bacteria at issue. Despite posing no risk to persons who normally encounter it in their environment, M. chimaera does pose a unique risk to those who become exposed to it through the Sorin 3T System during invasive surgical procedures.

The NTM Infection Lawsuit is Case No. 6:18-cv-01108-JTM-GLR, in the U.S. District Court for the District of Kansas.