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Getting open-heart surgery is risky enough, and you count on the surgeon and other medical professionals to make sure the operation and any post-procedure care go along smoothly. But, for a visible number of patients recovering from a supposedly successful operation, infections developed at the site months, if not years, later. Reports from the FDA link these instances to the Stöckert 3T heater-cooler system.

Introduced to the U.S. market in 2006 and sold primarily by LivaNova PLC, heater-cooler systems use a temperature-controlled water supply within its tank to then heat or cool the patient’s blood or body temperature during the procedure. While the machine itself doesn’t come in direct contact with the patient, it emits an aerosolized stream of water. If bacteria or other microorganisms have contaminated the supply, these go into the air, too, and from there can enter the patient’s chest cavity during the surgery.

Because of this, patients in both the U.S. and Europe have been exposed to and developed infections from Mycobacterium chimaera, a type of nontuberculous mycobacterium (NTM) found commonly in soil and water. In response, these patients and their loved ones have filed lawsuits against LivaNova and other manufacturers.

Background

From 2010 to 2015, the FDA received 32 adverse reports concerning infections from heater-cooler systems, including eight from the U.S. Over this period, unbeknownst to medical professionals and patients, the manufacturer changed the device’s design but never revised the instructions.

Starting in spring 2015, Swiss researchers identified a link between six patients infected from M. chimaera after open-heart surgery and the use of a contaminated heater-cooler system during extracorporeal circulation. A few months later, Clinical Infectious Diseases published similar findings.

Later in 2015, the Washington Post highlighted the difficulty of cleaning heater-cooler systems and the duodenoscope. These devices, both used in risky procedures, have potential to spread life-threatening infections to patients.

Along with these findings, several hospitals across the U.S. experienced NTM infection outbreaks. One, WellSpan York Hospital, had to notify 1,300 open-heart surgery patients potentially exposed to this bacteria. Out of this group, eight from 2011 to 2015 developed an infection, and for four of these cases, the condition became fatal.

In response, the Centers for Disease Control and Prevention issued recommendations to hospitals concerning the use of heater-cooler systems to prevent the spread of NTM. Specifically, they advised medical professionals to avoid using tap water during procedures.

By the end of 2015, inspections in Munich and Colorado found quality system, premarket clearance violations, and other issues concerning heater-cooler systems in hospitals. In response, the FDA issued the manufacturer a warning letter.

In 2016, another European paper identified a link between the M. chimaera found on infected cardiothoracic patients and the use of heater-cooler devices. At the same time, the FDA received more reports and decided to update its earlier warning, requiring healthcare facilities to take additional steps to reduce infection risks.

Furthermore, the FDA’s statement warned that the 500,000 patients undergoing open-heart surgery each year are at risk for an infection. Just in that past year alone, 28 more patients had to fight NTM infections related to a heater-cooler system.

Unfortunately, symptoms of NTM might not emerge until months later after surgery. From that point, the bacteria leads to a difficult-to-treat illness with a 50-percent survival rate. Patients find themselves having to get multiple surgeries to remove the infection or needing to take a course of toxic antibiotics.

It’s estimated that 250,000 patients per year get open-heart surgery, and in 60 percent of those, medical professionals use a heater-cooler system. Even if the water used is sterile, however, bacteria may grow in the device’s reservoir and stay there, thus making a patient’s risk of infection anywhere from 1 in 1,000 to 1 in 100, according to the CDC.

Lawsuits

Since these studies and reports have emerged, patients infected after open-heart surgery have sued LivaNova, in addition to other manufacturers, including Terumo, Cincinnati, and Maquet. In these claims, plaintiffs allege the infections and strokes experienced after a cardiothoracic procedure can be traced back to a heater-cooler system. Furthermore, they state the manufacturers knew about these risks early on but never warned the hospitals and surgeons using these devices.