LivaNova faces a heater-cooler infection lawsuit over allegations that their medical device causes serious and potentially deadly infections.

Plaintiffs Michael and Carol M. filed a heater-cooler infection lawsuit against LivaNova alleging that their Stockert 3T heater-cooler caused Michael to develop a dangerous infection.

The couple says that in February 2016, Michael underwent a triple coronary artery bypass graft and aortic valve replacement. LivaNova’s Stockert 3T device was used during this surgery.

In December 2016, Michael allegedly began experiencing kidney failure, weight loss, night sweats, fatigue, and unexplained fever. In February 2017, a full year after his surgery, Michael tested positive for a M. chimaera infection. The infection caused him to undergo “painful medical procedures and treatment” and forced to spend money on medical care and treatment, the couple claims.

M. chimaera infections are slow growing and can take months or years to develop. Due to the nature of the bacteria, it rarely causes illnesses outside of patients whose organs are exposed to the bacteria during surgery. Symptoms of an M. chimaera infection include fatigue, persistent fever, night sweats, muscle pain, joint pain, and unexplained weight loss.

The Stockert 3T Heater-Cooler regulates blood temperature during surgery by circulating water through tubes into a heat exchanger where blood is pumped into separate chambers during surgery. This helps keep blood and organs at the correct temperature during surgery where bypass is used.

The heater-cooler infection lawsuit alleges the Stockert 3T allows bacteria to become airborne and contaminate the surgical field. If the interior of the device is contaminated, bacteria can be aerosolized and forced out of the machine’s exhaust vent.

A public heath investigation in Switzerland in 2011 allegedly identified M. chimaera contamination in cooler-heater units. Later that year, the FDA allegedly visited a LivaNova plant in Munich, Germany to discuss safety concerns. LivaNova was allegedly advised regarding the M. chimaera contamination in their Stockert 3T units at this time.

More than four years later in 2015, LivaNova allegedly recalled their Stockert 3T instructions to include better cleaning procedures to reduce M. chimaera contamination.

According to the heater-cooler lawsuit, Michael’s experience is not an isolated incident. Allegedly, many hospitals across the country have experienced similar contamination and subsequent infections.

“The University of Iowa Hospitals and Clinics has confirmed multiple M. chimaera infections, including deaths, attributed to the 3T. […] Many hospitals have either discontinued using the 3T or have moved the 3T into a separate room to prevent contaminated aerosols from reaching the surgical field,” states the lawsuit.

Michael and Carol accuse LivaNova of knowing and understanding the defects related to their Stockert 3T device yet continuing to distribute it despite the risks. “[LivaNova] knew or should have known that design and/or manufacturing defects in the 3T renders it prone to bacterial colonization and transmission, regardless of the cleaning and disinfection procedures used,” the heater-cooler infection lawsuit alleges.

Michael and Carol accuse LivaNova of multiple counts of negligence, liability, breach of warranty, and misrepresentation. They seek a trial by jury, damages, court costs, and attorney’s fees.

The Heater-Cooler Infection Lawsuit is Case No. 1:18-cv-00480-ELH in the U.S. District Court for the District of Maryland.