For some patients, heart surgery infection has been linked with a device known as a cardiac heater-cooler, which is commonly used during such surgeries to regulate body temperature. Unfortunately, some cardiac heater-coolers may have become contaminated during manufacture, leading to heart surgery infection in some patients.

The U.S. Food and Drug Administration (FDA) has warned about the possibility of heart surgery infection from some contaminated cardiac heater-cooler devices.

In a growing number of lawsuits, patients claim that their heart surgery infection was caused by one of these contaminated devices.

Basics of the Cardiac Heater-Cooler Device

A cardiac heater-cooler device is commonly used during heart surgery to help regulate the patient’s body temperature of the patient, alternating between warming and cooling the patient’s blood as necessary. The system makes use of temperature-controlled water, which is then sent to warming and cooling blankets on the patient’s body.

However, some devices may allow the water to become contaminated, which can place the patient at serious risk of developing heart surgery infection. This may not be through direct contact between contaminated water and the patient; however, the water may aerosolize (move through the air) or travel through other parts of the device to come in contact with the patient.

Contaminated water in a heater-cooler device used during open-chest surgery may lead to serious heart surgery infection, according to warnings from the FDA and the CDC.

Cardiac heater-cooler devices are manufactured by a number of major companies, including LivaNova. The CDC has specifically warned about the LivaNova Sorin3T heater-cooler system, saying that some of these devices may have become contaminated during the manufacturing process. The contaminant? A bacterial species of nontuberculous mycobacterium (NTM), which can lead to heart surgery infection.

As a result of this contamination, the device was recalled in 2015 due to the “[p]otential colonization of organisms, including Mycobacteria.”

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 1.5 to 3 years.

More and more patients are filing adverse event reports with the FDA over heart surgery infection after the use of a cardiac heater-cooler during surgery.

Filing a Heart Surgery Infection Lawsuit

If you or someone you love has suffered from a heart surgery infection after 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 heart 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.