A man who says he developed a mitral valve repair infection has filed a lawsuit against the maker of a heater cooler unit that allegedly caused the infection.

Plaintiff James P. says he underwent open heart surgery for mitral valve repair in May 2014. During the surgery, he says, a Stockert 3T heater cooler unit made by LivaNova allegedly kept his blood and internal organs at a steady temperature.

James alleges he began experiencing shortness of breath, coughing and fatigue after his surgery. In March 2016, James purportedly underwent a bronchoscopy that tested positive for Mycobacterium chimaera, also known as M. chimaera. He claims he developed a mitral valve repair infection.

Origins of Mitral Valve Repair Infection

The Stockert 3T was made in Germany. The heater cooler device regulates blood temperature by circulating water through tubes and the blood is pumped into separate chambers. The water never comes into physical contact with the patient.

Water vapor does escape into the air through a vent in the Stockert 3T. When water vapor contaminated with bacteria enters the sterile operating room, this bacteria can enter the air and land in the open chest of the heart surgery patient. Without knowing at the time, the surgeon sews the patient back together with the bacteria trapped inside the body.

According to the mitral valve repair infection lawsuit, studies have shown the Stockert 3T aerosolizes M. chimaera when the unit is turned on. At least one study concluded the machines were likely contaminated with the bacteria during manufacturing.

In 2011, the FDA allegedly visited the factory in Munich to discuss concerns that contaminated Stockert 3T heater coolers were causing mitral valve repair infections.

The FDA reportedly informed LivaNova (then Sorin Deutschland) that “its 3Ts harbored dangerous bacteria and that it had failed to make a proper risk assessment for cleaning the devices to prevent bacterial infections in patients exposed in the operating room,” the lawsuit states.

In response, the manufacturer allegedly said such a patient risk was “not considered” because it was “not of concern.”

The FDA allegedly also told Sorin that their device disinfection advisory of every 14 days was insufficient because bacterial overgrowth had been noted in only a day and a half. As a result, new guidelines for sanitizing the Stockert 3T heater coolers were disseminated along with new guidance for practitioners recommending they change the tubing on the machines.

According to the mitral valve repair infection lawsuit, the Stockert 3T heater coolers are apt to encourage bacterial growth no matter how well the devices are cleaned and disinfected. The lawsuit alleges that manufacturing defects make it virtually impossible to sterilize the machine.

At least one medical facility reported to the FDA that even after a deep disinfection, new water hoses, three rounds of using the new cleaning procedures, and using filtered water, the Stockert 3T continued to produce high bacteria counts in the emitted vapor.

The Mitral Valve Repair Infection Lawsuit is Case No 1:18-cv-01825-MSK in the U.S. District Court, Adams County, Colorado.