An infected heart surgery device is being blamed for several life-threatening infections in more patients than originally believed.

The cardiac heating/cooling device is used to keep the blood and organs at a steady temperature during open 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.

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

Tests have 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. The bacteria can be found naturally in soil and water. How the bacteria entered the medical machines remains a mystery.

People who have had open heart surgeries and those with weakened immune systems are most susceptible to infection.

Infected Heart Surgery Device Creates Airborne Problem

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

These 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.

FDA and CDC Issue Warnings of Possible Infection

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 Stockert 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.

“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 in October.

U.S. patients who underwent open heart surgery prior to 2014 should be aware of symptoms indicating possible infection from an infected heart surgery device. The CDC says to make note of night sweats, muscle aches, weight loss, fatigue, pus developing around an incision site or unexplained fever.

If you or someone you know has undergone heart surgery where an infected open heart surgery device was used, you could be eligible for compensation from the device’s manufacturer.