A device used in open-heart surgery may be putting patients at risk for potentially deadly heart surgery injury.

The device at issue regarding heart surgery injury is the Stöckert 3T Heater-Cooler system.

It was originally manufactured by the Sorin Group Deutschland, and some models still in use may have been branded under the Sorin name. Sorin has since been taken over by Italian company LivaNova PLC.

The Stöckert 3T system is used in conjunction with other surgical devices to regulate patients’ body temperature during open-heart surgery. It works as a source of temperature-controlled water to heat exchangers and warming-cooling blankets.

FDA Warns of Possible Heart Surgery Injury

The FDA issued a safety communication on this subject in June 2016. Reports of post-operative infections in the U.S. appear to be linked to contamination of Sorin 3T systems that itself could have originated in the devices’ manufacturing process.

The 3T system is designed so that the water inside it does not come into contact with the patient. But according to the FDA, water may be able to move around inside the machine, potentially allowing contaminated water to foster colonies of Mycobacterium chimaera.

The FDA says contaminated 3T systems could allow mycobacteria to be released into the air of the operating room through the system’s exhaust mechanism.

Once airborne, these mycobacteria may be able to find their way to the patient’s open surgical wound, putting the patient at risk for a post-operative infection and heart surgery injury.

M. chimera is a kind of nontuberculous mycobacterium, or NTM. Bacteria like this are actually fairly common, and usually they don’t present a serious health risk. But for patients in open heart surgery, an NTM infection could put them at risk for serious heart surgery injury or even death.

A study conducted in Europe found a link between the NTM bacteria sampled from actual patient infections and environmental samples taken from the Sorin manufacturing facility in Germany.

Testing conducted at the 3T manufacturing facility in August 2014 revealed contamination of M. chimera on the production line and in the facility’s water supply.

According to the FDA, the results of this study suggested a direct link between contaminated 3T heater-coolers and the type of NTM that caused these infections.

Symptoms to Watch For

Reports have already been lodged with the FDA concerning patients in the U.S. who developed M. chimera infections after undergoing open-heart surgery in which a Sorin 3T system was used.

While the risk of developing such an infection is low, the potential heart surgery injury that can result can be considerably damaging. These infections were fatal in about half of the cases that the FDA was aware of between 2010 and 2015.

An NTM infection does not come on quickly. It may not manifest until several weeks, months, or sometimes even years after surgery.

Symptoms that could be related to an NTM infection include night sweats, fatigue, nausea, joint pain, muscle pain, or a fever that can’t otherwise be explained. Patients may also notice redness, warmth or purulence around the site of their surgical incision.