LivaNova PLC, manufacturers of the Sorin 3T Heater-Cooler System, faces a recent open heart surgery infection lawsuit filed by a woman alleging she suffered from severe adverse side effects and complications that resulted from the device’s use.

Plaintiff Donrue B. has filed the open heart surgery infection lawsuit in Alabama federal court on April 24, 2018.

According to the open heart surgery infection lawsuit, Donrue says that she developed a bacterial infection following her open heart surgery procedure.

She underwent a coronary artery bypass grafting surgery on April 25, 2016 at Providence Hospital. During the procedure, the 3T Heater Cooler System was used. It is allegedly what led her to suffer from a number of different symptoms indicating that she had contracted a bacterial infection.

Following her procedure, she says that she received a letter from Providence Hospital. It indicated the following: “The Center for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating reports that during certain open-heart surgeries, the device used to heat and cool the blood (called a Soring Stockert 3T Heater-Cooler device) has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a species of bacteria known as nontuberculous mycobacterium (NTM)…”

The letter continued to report that those infected experienced symptoms of night sweats, muscle aches, weight loss, fatigue, unexplained fever and redness/drainage from sternal wound site.

The open heart surgery infection lawsuit was filed on multiple counts including design defect, manufacturing defect and warnings defects.

Since her surgery, Donrue reports that she did experience symptoms indicating she suffered from an NTM infection.

Overview: Open Heart Surgery Infection

Since October 2015, thousands of patients whom have undergone various procedures such as liver, lung and heart surgeries were notified by hospitals across the country that they had been exposed to a deadly and rare bacterium linked to the LivaNova Sorin 3T Heater Cooler System.

As a result, thousands of lawsuits have been filed against LivaNova over patient infection alleged to stem directly from the device. The bacteria at issue is a subspecies of NTM known as M. Chimaera. Although they rarely cause illness and are often found in the environment in soil, it poses a unique risk to patients during invasive surgical procedures.

The Stockert 3T device is used during invasive surgical procedures to maintain and regulate patient body temperature. The device works by maintaining the temperature of a patient’s vital organs through the proper circulation of blood.

However, the device works by storing water in a tank. The water in the tank can become a reservoir for bacteria. Even though the water never comes in to direct contact with the patient, the bacteria can aerosolize thereby exposing the patient to a deadly infection.

The Open Heart Surgery Infection Lawsuit is Case No. 1:18-cv-00194-MU, in the U.S. District Court for the Southern District of Alabama.