The Montreal Heart Institute has filed a lawsuit against medical device manufacturer LivaNova, alleging that its cardiac heater cooler device could have spread an NTM infection to thousands of its patients.

In 2016, an article was published in Consumer Reports magazine about the possibility of a contaminated cardiac heater cooler device causing an NTM infection. After the article came out, the Montreal Heart Institute contacted thousands of its patients that had undergone heart surgery with the use of a cardiac heater cooler device, warning them of the risk of developing an NTM infection, a type of bacterial infection.

The Montreal Heart Institute then filed a $345,000 lawsuit against LivaNova, the manufacturer of the device in question. According to the lawsuit, MHI bought six of LivaNova’s cardiac heater cooler devices back in 2007 and used them during surgeries with thousands of patients. Then, in 2015, LivaNova contacted MHI to warn about the possibility that the devices had been contaminated, which MHI confirmed through testing. LivaNova sent instructions for how to decontaminated the devices, the lawsuit notes, but these efforts were ineffective, and the machines were then replaced in 2016.

MHI contacted more than 8,000 patients because of the risk of NTM infection, spending more than $200,000 to effectively alert patients of the possible danger. On top of this cost, the institute also spent money to decontaminate the machines, as well as replace them with new ones once that didn’t work. Although MHI has requested that LivaNova compensate for these expenses, the manufacturer has so far refused.

What is a Heater Cooler Device?

Heater cooler devices are used during heart surgeries to regulate the patient’s body temperature, warming and cooling the blood as necessary. These devices use temperature-controlled water to send to warming and cooling blankets. A number of companies, including LivaNova, manufacture these heater cooler devices. Unfortunately, some of these devices may have become contaminated, placing patients at risk of developing an NTM infection.

Risk of NTM Infection

The temperature-controlled water of a heater cooler system may become contaminated. Then, the contaminated water may be able to move through other parts of the device or even through the air, through the device’s exhaust vent, and toward the patient. During a heart surgery, contamination in the air can lead to an NTM infection.

However, it may take a long time for the infection itself to surface. Patients may not even develop symptoms of the infection after heart surgery for months or even years after the initial exposure. A growing number of patients are filing cardiac surgery infection lawsuits over allegedly contaminated devices used during surgery.

The spread of NTM infection through contaminated heater cooler devices is significant. Between January 2010 and February 2016, the U.S. Food and Drug Administration (FDA) received 180 adverse event reports regarding heater cooler devices, at least 45 of whom were American patients, and at least nine of whom died from the infection.

Indeed, though an NTM infection is relatively harmless, it can actually become deadly if it moves into a chest cavity or a prosthetic heart valve.

Filing a Heater Cooler Lawsuit

If you or someone you love has suffered from an NTM infection after heart surgery with the use of a heater cooler device, you may be able to join the growing number of cardiac surgery infection lawsuits.

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