Many heart surgery patients have taken to filing a Stockert 3T heater cooler lawsuit against LivaNova PLC (formerly Sorin Group Deutschland), accusing the company of marketing a cardiac heater-cooler device that caused development of a Mycobacterium chimaera (M. chimaera) infection following heart surgery.

The Sorin Stockert 3T heater cooler is one of the most popular heater cooler devices used during open heart surgery. Yet patients who have filed a Stockert 3T heater cooler lawsuit allege these popular devices are putting patients at risk for a dangerous, slow-growing bacterial infection.

Stockert 3T Heater Cooler Background

Heater cooler units are used during open heart surgery to maintain a patient’s safe body temperature. The importance of maintaining safe body temperature is so that blood can continue circulating properly providing oxygen and important nutrients as required. Every year, there are roughly 250,000 heart bypass surgeries performed in the U.S., and of these, 60 percent use heater cooler units to keep patients’ body temperatures safe.

A heater cooler unit works by storing water in a tank. The water can then be kept at specific temperatures for heating up or cooling down a patient’s body as needed.

However, according to a recent Stockert 3T heater cooler lawsuit, the device creates a dangerous risk of bacterial infection. M. chimaera bacteria have been found colonizing the inside of some Stockert 3T heater cooler units. This contamination can cause bacteria to be forced out of the device’s exhaust vent and into the air of the operating room, where it can then find its way to the open surgical site on the patient’s body and potentially cause a dangerous mycobacterial infection.

The contraction of a cardiac surgery infection can be difficult to diagnose. To make matters worse, it can even take months and even years to manifest. Symptoms of a cardiac surgery infection can include night sweats, sudden weight loss, fatigue, muscle aches, and unexplained fever. The contraction of a nontuberculous mycobacterium can produce serious complications, even if the bacteria is relatively harmless on its own. With an already weakened immune system, it can cause patients to suffer serious adverse effects.

CDC and FDA Warnings

A safety communication was issued by the U.S. Food and Drug Administration (FDA) in June 2016. The announcement warned healthcare providers of the risks of M. chimaera infection reported with heater cooler units.

The FDA made the announcement after receiving several reports of patient infections. According to the FDA, the agency “received reports of U.S. patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T.”

An October 2016 update warned staff and facilities to be aware that heater cooler units manufactured prior to September 2014 may have been shipped from M. chimaera-contaminated factories.

The Centers for Disease Control and Prevention (CDC) also warned of contaminated heater cooler units and the risks of patient infection following open heart surgery. According to the CDC, “in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.”

Patients who developed an M. chimaera infection after surgery with one of these devices may be in a position to file a new Stockert 3T heater cooler lawsuit.