LivaNova PLC and its associates are facing legal action from a South Carolina man over problems with a device commonly used in cardiac surgery.

Plaintiff Van B. underwent an orthotopic liver transplant on June 11, 2015 to treat his end stage liver disease.

During his surgery, defendant LivaNova’s 3T Heater Cooler System was used to control the temperature of his body. Van alleges use of the 3T led to a dangerous infection.

According to the 3T Heater Cooler System lawsuit, the temperature control device was used to increase the chances of success.

However soon after having the new organ implanted, Van had to return to the hospital less than ten days later due to fever and abdominal pain.

Throughout the next year, Van would continue to return to the hospital complaining of fever and abdominal complications and would be discharged with an antibiotic prescription.

CT scans revealed an abscess forming inside the abdomen, which eventually prompted physicians to collect culture samples.

On Sept. 16, 2015, Van’s doctors performed a wound debridement. Cultures taken from his abdomen tested positive for Mycobacterium abscessus (NTM). He was discharged with orders to be monitored by home healthcare.

According to Van’s 3T Heater Cooler System lawsuit, he received the same aggressive antibiotic treatment for over thirteen months, and he continues to suffer from the NTM bacterial infection.

Van filed this lawsuit after learning that he and thousands of other patients undergoing major liver, lung, or cardiac surgery have been exposed to this potentially deadly pathogen.

Overview of 3T Cardiac Surgery Heater Cooler System Allegations

While 3T Heater Cooler Systems are commonly used in cardiac surgery, they have allegedly been inducing these infections in other transplant patients like Van. While this bacterial infection may be treatable if diagnosed at an early state, it can become deadly if left to develop.

The 3T Heater Cooler System is a water tank device that circulates water though tubes into a heat conversion system for temperature control. Even though this device does not contact the patients directly, the FDA states “there is potential for contaminated water to enter other parts of the device and aerosolize.”

This means that bacteria can be released into the air during surgery, and ultimately into the same environment as the patient. These devices are used in many of the 250,000 open cardiac surgery procedures performed every year. Approximately 60% of these devices have been linked to possibly deadly bacterial infections.

Both the FDA and the CDC are warning patients and the medical community that 3T Heater Cooler Systems may induce deadly bacterial infections. Even though the 3T Heater Cooler Systems are very important to patients undergoing cardiac surgery, health officials are recommending physicians explore alternatives.

Van states that he never would have agreed to use the 3T Heater Cooler System if he had known of the possible bacterial infections linked to the device. Van is filing this 3T Heater Cooler lawsuit against LivaNova for allegedly failing to warn him about the possibility of infection.

This 3T Heater Cooler System Lawsuit is Case No. 3:16-cv-785, in the U.S. District Court for the Western District of Northern Carolina, Charlotte Division.