A cardiac heater-cooler unit is being blamed for several life-threatening infections in patients who have undergone heart surgery.

Patients have filed lawsuits against the manufacturer of the Stockert 3T Heater-Cooler System, made by LivaNova PLC, formerly Sorin Group Deutschland.

The unit is sometimes known as the Sorin 3T Heater-Cooler System.

The devices allegedly were contaminated with Mycobacterium chimaera, which can lead to serious illness or death. Manufactured in Germany, the cardiac heater-cooler unit has been linked to patient deaths related to infections since January 2014, according to the FDA.

Tests have reportedly concluded that the strain of bacteria found in the machines is the same as that found in environmental samples from the production and servicing facility in Germany.

Cardiac Heater-Cooler Unit Bacterial Contamination

The cardiac heater-cooler unit helps keep a patient’s organs and circulating blood at the correct temperature during an operation.

The machine uses water to regulate temperature control, and even though the water does not come in contact with blood or organs, there is the possibility that evaporating water can send contaminates into the air. The device also has an exhaust vent that could send bacteria into the air.

The airborne bacteria can allegedly land in the chest cavity during the operation and plant seeds of infection that can develop months or years after exposure.

Cardiac heater-cooler units are used during 250,000 open-heart bypass surgeries every year. Nearly 60 percent of those machines are the German-made models that have been linked to possibly deadly infections since 2006.

Warnings from the FDA and CDC

In October 2015, the FDA issued its first safety communication regarding the cardiac heater-cooler units because the agency said 32 medical device reports alleging infections from the units had been reported.

In June 2016, the FDA recognized that the bacterial infections were linked to the 3T heater-cooler units made in Germany.

In October 2016, the FDA recommended further warnings to health officials regarding the prevention of the spread of the infection.

These recommendations include using new accessories, tubing and connectors with the devices, and directing the exhaust fan away from the patient.

The FDA also warns patients to be aware that there is an increased risk of infection if you receive a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product, or have had a heart transplant.

So far, hospitals in Iowa, Michigan and Pennsylvania have reported infections. A total of 28 cases have been identified in the United States, and a number of others in Europe.

“Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger,” according to a CDC (Centers for Disease Control) report released last week.

Cardiac Heater-Cooler Unit Lawsuits

Open-heart surgery patients from Pennsylvania filed a cardiac heater-cooler unit class action lawsuit in February 2016.

The lawsuit alleges that LivaNova knew or should have known about the problems with the device that exposed patients to “potentially fatal bacteria” during surgery.

If you or someone you know developed an infection after open-heart surgery during which a cardiac heater-cooler unit was used, you could be eligible for compensation from the device’s manufacturer.