A number of hospitals located in central Indiana have issued warnings to patients who have undergone open-heart surgery advising them that they may be at risk of serious infection.

The heart surgery infection riskstems from a medical device that was used patients during their open-heart surgery. The device is manufactured by LivaNova and is known as the Stockert 3T heater-cooler.

According to the Centers for Disease Control and Prevention, these cardiac heater-coolers were likely contaminated with a rare bacteria during the manufacturing process.

Overall, approximately 150,000 heart bypasses in the United States alone are performed using this particular device each year, according to the CDC.

Cardiac heater coolers, such as the Stockert 3T are used to regulate patient temperature during open-heart surgery.

By keeping the patient’s circulating blood and organs at optimal temperature during surgery, the threat of complications is lessened, the risk of bleeding is reduced and surgical outcomes are generally more favorable.

At this time, Indiana hospitals have not reported any confirmed infections, but are warning patients nonetheless. Hospitals across the country are doing the same to their patients who underwent open-heart surgery where the cardiac heater-cooler was used.

In particular, five hospitals used the medical device, and advised its patients of the heart surgery infection risk. Methodist, Indiana University, Riley Hospital for Children in Indianapolis, Bloomington, and Arnett in Lafayette hospitals all used the device, according to Indiana University Health.

Approximately 6500 patients were notified of the potential heart surgery infection risk.

Additional hospitals not affiliated with Indiana University also used the device. Franciscan Health, with hospitals located in Crown Point, Indianapolis and Lafayette used the cardiac heater cooler and notified 800 patients. Community Heart and Vascular hospital notified 600 patients, and the Richard L. Roudebush VA Medical Center notified 430 of its patients.

Patients who specifically had open-heart surgery at the Indiana hospitals from January 1, 2012 through November 30, 2016 were notified of their heart surgery infection risk.

Rare Mycobacterium Linked to Heart Surgery Infection Risk

The cause of heart surgery infection risk is a rare non—tuberculosis mycobacterium known as Mycobacterium abscessus, or m. abscessus.

Typically, doctors do not even consider this particular type of mycobacteria when evaluating patients for infection because it is so rare.  It is only when doctors are specifically notified that a patient has been exposed to this type of mycobacteria do they even consider it as a possibility.

Patients who are infected with Mycobacterium abscessus may be able to be treated with an extended course of antibiotics. Other times, removal of the infected tissue can also successfully treat the patient. However, sometimes these measures are unsuccessful and the patient may die if the infection cannot be controlled.

Patients Take Legal Action Following Heart Surgery Infection Risk

A number of lawsuits have already been filed against the manufacturer of these cardiac heater-coolers because of the heart surgery infection risk and subsequent problems brought about by the mycobacterium infection.

These lawsuits have alleged the device is defective and that the manufacturer acted negligently when it failed to protect the safety of individuals who use the device during surgery. There have also been lawsuits of alleged loss of spousal companionship as well as wrongful death claims.