Tamara Burns  |  June 23, 2017

Category: Legal News

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cardiac heater cooler ntm infectionHeart surgery patients may be dealing with more than they bargained for after cardiac bypass surgery. Thousands of patients have been notified that they may be at risk for developing NTM infections, or non-tuberculous mycobacteria infections, if a particular medical device was used in the operating room during their surgery.

The particular piece of equipment under scrutiny is the Stockert 3T cardiac heater-cooler device made by LivaNova PLC. These devices are intended to keep patients warm while they are undergoing heart surgery. When a patient’s temperature can be regulated during surgery, improved surgical outcomes can be expected, and bleeding can be lessened, contributing to a more favorable surgical experience.

The portable device uses water to stabilize the patient’s temperature. However, no water actually comes into contact with the patient. The problem with these devices is that a mycobacterium, known as non-tuberculous mycobacterium, can grow in the water of the cardiac heater-cooler unit. During the machine’s regular use, these bacteria can be sprayed into the operating room when the water is aerosolized as part of the equipment’s normal functioning.

What are NTM Infections?

These mycobacteria that are responsible for the NTM infections are typically found in soil or water. They normally do not pose a problem for most humans when they are inhaled, as the body’s immune system is able to clear the infection effectively.

However, for those undergoing cardiac bypass surgery, NTM infections can invade a body that is weak from illness and from the surgical procedure itself. For those who have NTM infections, inflammation of the respiratory system results, with patients ultimately experiencing shortness of breath, a cough, weight loss and ongoing fatigue.

Initial symptoms of NTM infections are nonspecific, and since they are so rare, most doctors may miss the diagnosis unless they specifically know that a patient has been exposed to mycobacteria. Initial symptoms of NTM include night sweats, having less energy than usual and loss of appetite. Typically, it is not until symptoms worsen or recur that a patient begins to take notice and consult a physician.

Treatment of NTM infections usually includes a long course of antibiotics, up to a year or two. Taking antibiotics can lead to other problems, as taking just a single week-long course can permanently alter the balance of good and bad bacteria and yeast in the gut, leading to long-term digestive issues. Other antibiotics may have serious side effects like kidney failure or may cause a fatal allergic drug reaction, so using antibiotics brings its own set of consequences.

How Did Heart Surgery Patients Become Exposed to Mycobacteria that Cause NTM Infections?

The makers of the cardiac heater-cooler found that during the manufacturing process, the equipment was likely contaminated with mycobacteria. Upon the equipment’s use, when the water in the machine turned into aerosol that was released from the machine, it got into the operating room and could travel to the patient who could be exposed to the bacteria and acquire NTM infections.

The company has since informed hospitals of the potential contamination of the cardiac heater-cooler units, and hospitals should have directly informed patients who had heart surgery where the cardiac heater-cooler was used so they can be aware of potential NTM infections.

If you have been diagnosed with an NTM infection following your heart surgery, you may be eligible to seek legal compensation from the product’s manufacturer to compensate for your injuries. An experienced attorney familiar with NTM infections caused by cardiac heater-cooler devices can provide you with a free case review and can guide you in your legal options.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The cardiac heater-cooler attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, cardiac heater-cooler lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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