Some patients who have suffered from an open-chest surgery infection may be able to connect the infection with a contaminated device used during surgery. The U.S. Food and Drug Administration (FDA) has warned about the possibility of developing an open-chest surgery infection due to the use of a contaminated heater-cooler system.

Some patients have begun filing lawsuits alleging that their open-chest surgery infection was caused by one of these contaminated devices. If you or someone you love has suffered from an open-chest surgery infection after the use of one of these devices, you may be able to file a heater-cooler lawsuit.

What is a Heater-Cooler Device?

A heater-cooler device is used during open-chest surgery to help regulate the body temperature of the patient. The device does this by alternately warming and cooling the patient’s blood as deemed necessary. The system uses temperature-controlled water, which is then sent to warming and cooling blankets on the body.

However, if this water becomes contaminated, patients may be placed at serious risk. Though there is no direct contact between the water in a heater-cooler system and the patient, it is possible that the water may become aerosolized (move through the air) into the operating room.

Contaminated water during a major procedure could lead to a serious open-chest surgery infection, according to warnings from multiple agencies including the FDA and the Centers for Disease Control.

Multiple medical device manufacturers make heater-cooler devices, including LivaNova. The CDC issued a warning over the LivaNova Sorin3T system, noting that some of these devices may have become contaminated during the manufacturing process. The contaminant is a bacterial species of nontuberculous mycobacterium (NTM), which can cause a serious open-chest surgery infection. Indeed, the contamination led to an FDA recall in 2015 due to the “potential colonization of organisms, including Mycobacterium.”

More and more patients are filing adverse event reports with the FDA over open-chest surgery infection. An NTM infection after heart surgery may indicate that the bacteria grew in the heater-cooler water tank.

Patients may not actually develop symptoms of the infection for months or even years after the initial exposure during surgery. Reports indicate that the average cardiac surgery patient linked with heater-cooler contamination failed to show symptoms of infection after heart surgery for one and a half to three years.

Filing an Open-Chest Surgery Infection Lawsuit

If you or someone you love has suffered from an open-chest surgery infection after heart surgery with the use of a heater-cooler device like the Sorin 3T System, you may be able to file a lawsuit or join a class action open-chest surgery infection lawsuit.

While filing a lawsuit cannot take away the physical and emotional effects of such a serious infection, or bring a loved one back to life, it can help to alleviate the financial burden caused by medical expenses and lost wages.