An Alabama woman recently filed a lawsuit against medical device manufacturer LivaNova, alleging she suffered from an infection after heart bypass surgery due to use of a defective cardiac heater-cooler.

The plaintiff, Donrue B., says she underwent a coronary artery bypass grafting surgery in April 2016. The surgery allegedly involved the use of a Sorin 3T Heater Cooler System. Unfortunately, her lawsuit claims, she later began developing symptoms indicating infection.

She soon thereafter received a letter from the hospital explaining that she had been exposed to the bacterial infection Mycobacterium chimaera through the heater-cooler device.

Symptoms of infection after heart bypass surgery cited in the notice included night sweats, muscle aches, weight loss, fatigue, unexplained fever, and redness or drainage from the sternal wound site.

Donrue filed her LivaNova lawsuit on multiple counts, including design defect, manufacturing defect, and negligence. The lawsuit was filed on April 24, 2018, in the U.S. District Court for the Mobile Division of the Southern District of Alabama.

Donrue is not the first patient to come forward with allegations of infection after heart bypass surgery associated with a defective heater-cooler device. In October 2015, hospitals all across the United States began informing patients that, because of a contaminated heater-cooler device, they had been exposed to a bacterium that could lead to infection after heart bypass surgery. The specific device was the Sorin 3T Heater Cooler System from LivaNova, which may have affected heart, lung, and liver surgery patients.

Heater Cooler Device Basics

A heater cooler device is often used during an open-chest surgery to help regulate the body temperature of the patient, alternately warming and cooling the patient’s blood as deemed necessary. The system uses temperature-controlled water, which is then sent to warming and cooling blankets on the body. However, if this water becomes contaminated, patients may be placed at serious risk.

Cardiac Heater Cooler Complications

Though there is no direct contact between the water in a heater-cooler system and the patient, it is possible that the water may aerosolize (move through the air) or even travel through other parts of the device that may come in contact with the patient. Contaminated water used during a major surgery could lead to a serious infection after heart bypass surgery, multiple agencies—including the FDA and the Centers for Disease Control—have warned.

More and more patients are filing adverse event reports with the FDA over infection after heart bypass surgery and other major surgical procedures using this device.

An infection after heart bypass surgery may indicate that the bacteria grew in the heater cooler water tank. In many cases, patients may not actually develop symptoms of the infection for months or even years after the initial exposure during surgery. Reports indicate that the average cardiac surgery patient linked with heater cooler contamination failed to show symptoms of infection after heart surgery for years.

Filing a Contaminated Heater Cooler Lawsuit

If you or someone you love has suffered from an infection after heart bypass surgery with the use of a heater cooler device like the Sorin 3T system, you may be able to file a lawsuit or join a class action heater cooler infection lawsuit.

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

The Infection After Heart Bypass Surgery Lawsuit is Case No. 1:18-cv-00194-MU, in the U.S. District Court for the Mobile Division of the Southern District of Alabama.