There are current lawsuits being filed against the makers of a cardiac heater-cooler device by patients alleging the heater- coolers exposed them to the bacteria Mycobacterium chimaera (M. chimaera) during surgery–leading to a cardiac surgery infection.

The Sorin Stockert 3T heater-cooler is a common device used for invasive surgeries, including open heart surgery. It is one of the most popular heater-cooler systems manufactured by the German company LivaNova PLC, formerly known as Sorin Deutschland GmbH.

What is LivaNova’s 3T Heater-Cooler?

The importance of a heater-cooler unit and why it can be so critical during invasive surgical procedures is because the device maintains safe temperature for the body and vital organs.

With a safe body temperature throughout an invasive surgical procedure, the blood can continue circulating properly. Throughout the United States there are roughly 250,000 surgical procedures performed every year, according to the National Library of Medicine. Of these procedures, approximately 60 percent use a heater-cooler unit, according to the Centers for Disease Control and Prevention (CDC).

How the heater-cooler device works is by storing water in a tank. Throughout a procedure, the water in the tank is kept at a specific temperature to cool or heat a patient’s body temperature or blood as needed.

However, allegations being brought up against LivaNova’s 3T heater-cooler unit is that the tank can be a reservoir for bacteria. The water in the tank can become contaminated and aerosolized. This can, therefore, cause patient infection during an invasive procedure.

Patients who have undergone invasive surgical procedures, such as cardiac surgery can suffer a severe and possibly fatal result from a cardiac surgery infection resulting from a contaminated 3T heater- cooler unit.

Cardiac Surgery Infection

Although nontuberculous mycobacterium is a relatively harmless bacteria, if it does wind up causing a cardiac surgery infection a multitude of problems may occur. This is especially the case once a patient does possess a weakened immune system, a likely occurrence in patients undergoing cardiac surgery.

A cardiac surgery infection can also take months and even years to manifest. Some of the symptoms also mimic other benign conditions, making it more difficult to diagnose. Some symptoms of a cardiac surgery infection include: night sweats; sudden weight loss; unexplained fever; fatigue; and muscle aches.

FDA & CDC Warnings

The U.S. Food and Drug Administration (FDA) issued a safety communication to healthcare providers in June 2016 about the risk of heater-cooler units in causing patient infection. They announced that 3T heater-cooler devices, manufactured by LivaNova, were linked to M. chimaera infections in patients undergoing surgery.

The FDA states that they “received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T.”

Recommendations for health care facilities and staff using heater-cooler devices was issued in an updated statement made in October 2016. The updated announcement asked facilities and staff to be aware that the “units may have been shipped from the factory contaminated with M. chimaera.” This updated announcement pertains to units manufactured before September 2014.

The recommendations that followed told health care providers of the possibility that their patients had become infected with the M. chimaera bacteria and to also follow the CDC’s recommendation for establishing patient follow up and patient surveillance.

The CDC’s recommendation was established within its Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units, updated in 2015.