A Florida man recently filed a lawsuit against LivaNova, alleging that the use of the manufacturer’s cardiac heater cooler device during surgery led to a serious bypass surgery infection.

The plaintiff, Joseph S., underwent coronary artery bypass graft surgery on Jan. 31, 2014. During surgery, he says, a Sorin 3T heater cooler system manufactured by LivaNova was used as a method of regulating his body temperature.

Unfortunately, in October 2016, Joseph allegedly began to suffer from serious symptoms indicating bypass surgery infection. These symptoms included fatigue, myalgias, arthralgias, fevers, cough, and weight fluctuation. He soon thereafter received notice from the hospital where his surgery was performed that its heater cooler devices may have been exposed to a nontuberculous bacterium, Mycobacterium chimaera, capable of causing bypass surgery infection.

Joseph says he was diagnosed with an NTM disease associated with this bacterium in December 2016, leading him to undergo an aggressive antibiotic treatment. However, the bypass surgery infection has not gone away, he says, and his health continues to suffer as a result.

Joseph filed his bypass surgery infection lawsuit on July 5, 2018, in U.S. District Court in Tampa, Florida. The lawsuit was filed on multiple counts, including design defect, manufacturing defect, failure to warn, negligence, and several others. The plaintiff’s wife Pamela S. also filed on one count of loss of consortium.

What is a Heater Cooler Device?

A heater cooler device is used during an open-chest surgery to help regulate the body temperature of the patient. The device does this by 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.

Though there is no direct contact between the water in a heater-cooler system and the patient, it is possible that the water may become aerosolized (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 an open-chest surgery could lead to a serious bypass surgery infection, 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 bypass surgery infection. An NTM infection after heart surgery may indicate that the bacteria grew in the heater cooler water tank.

Filing a Bypass Surgery Infection Lawsuit

In many cases, patients may not actually develop symptoms of an NTM 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.

If you or someone you love has suffered from a bypass surgery infection after open heart 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 Bypass Surgery Infection Lawsuit is Case No. 8:18-cv-01615-JSM-AEP, in the U.S. District Court for the Tampa Division of the Middle District of Florida.