Heater-cooler devices are often used to adjust blood temperature during heart surgery, but these devices may be linked with mycobacterial infection due to contamination.

The U.S. Food and Drug Administration (FDA) is conducting an ongoing investigation into the connection between heater-cooler devices and mycobacterial infection. Though the investigation is ongoing, the FDA has warned about the potential risk associated with heater-cooler devices.

A growing number of heart surgery patients are reporting suffering from a mycobacterial infection and allege their infection was caused by a contaminated heater-cooler device. If you or someone you love has suffered from a mycobacterial infection after undergoing heart surgery with the use of a heater-cooler device, you may be able to file a lawsuit.

What is a Heater-Cooler Device?

Heater-cooler devices are used during heart surgeries to adjust the patient’s blood temperature by warming or cooling the blood as deemed necessary with temperature-controlled water sent through blankets. However, the water in the water tanks may have become contaminated in some of these devices. Although the water does not come into direct contact with patients, it may be able to aerosolize (move through the air) to transmit bacteria through the device’s exhaust vent and affect the patient’s surgical site.

A patient infected by a contaminated heater-cooler device may end up with a mycobacterial infection strain known as Nontuberculous Mycobacteria (NTM).

A number of companies manufacture these heater-cooler devices, including LivaNova. The LivaNova Stockert 3T Heater-Cooler System has been linked throughout the FDA’s investigation with mycobacterial infection caused by contamination.

The Centers for Disease Control (CDC) has even warned about the risk of mycobacterial infection from LivaNova heater-cooler devices, noting that they might have become contaminated during the manufacturing process with NTM. LivaNova’s Sorin3T device was recalled by the FDA in July 2015 for its potential link to mycobacterial infection.

Some patients who have been affected by mycobacterial infection after heart surgery utilizing a heater-cooler device are coming forward with lawsuits against the device manufacturer.

Unfortunately, it can be difficult to make the connection between heart surgery and a later mycobacterial infection. This is because symptoms of a mycobacterial infection may not appear for months or, in some cases, even years after the initial exposure to the contaminated device during surgery. This span of time allows for significant disconnect between the exposure and the subsequent illness.

Filing a Lawsuit Over Heater-Cooler Mycobacterial Infection

Patients may be unaware that they may be able to file a lawsuit over these complications.

If you or someone you love has suffered from a mycobacterial infection after heart surgery with the use of a heater-cooler device that may have been contaminated, you may be able to file a lawsuit or join a class action mycobacterial infection lawsuit.

While filing a mycobacterial infection lawsuit cannot take away the physical and emotional effects caused by infection after heart surgery, it can help to alleviate the financial burden caused by medical expenses and lost wages.