Consumer complaints and lawsuits say that some heart surgery complications occur after the procedure because of issues with tools used during the surgery like cardiac heater coolers.

Although those devices are a critical part of protecting the patient from in-procedure complications, they allegedly can cause bacteria to get inside the human body and cause severe infections later.

Plaintiffs James M. and Mary M. recently filed a lawsuit against LivaNova PLC and other companies for issues associated with the use of a cardiac heater cooler.

The cardiac heater cooler device is used during surgery to keep the patient’s body warm, but unfortunately, the cardiac heater cooler device has allegedly been linked to bacterial infections when used in open heart surgeries.

In April 2018, the FDA and LivaNova recommended using a deep cleaning service to clean the heater cooler devices manufactured by the LivaNova under the 3T line. The impacted devices are those that contained visible bio-film or suspected contamination.

Heater cooler devices are necessary for use during surgery to cool or warm patients as part of the procedure. The heater cooler devices come with tanks that allow temperature controlled water or the use of cooling or warming blankets through closed water circuits.

The plaintiffs in the heart surgery complications lawsuit argue that they were never informed about the possibility of potential contamination due to an allegedly unreasonably dangerous and defective Sorin 3T heater cooler system that was distributed, manufactured, and sold by the defendants.

According to James and Mary’s lawsuit, the Sorin 3T system is designed to provide temperature controlled water to heat, exchange or devices, such as cardioplegia heat exchangers or cardiopulmonary bypass heat exchangers. The defendants initially submitted their approval through the FDA through the 510(k) fast track program that does not require comprehensive testing in line with other FDA approval methods.

In July 2015, the FDA issued a class 2 recall of the Sorin 3T system due to the possibility of mycobacteria causing life threatening infections when the heater cooler device was used during surgery.

The lawsuit against LivaNova alleges that the defendants knew prior to 2015 that the promotions that the device was safe and effective were misleading and put patients at serious risk for injuries.

The patient in this specific case, James, allegedly underwent coronary artery bypass surgery in April 2016 in Texas. During that time, they say the surgical team used the heater cooler device to assist with the rewarming and cooling of his blood. In the months following the coronary artery bypass procedure, however, James says he developed heart surgery complications, a critical post-operative infection, that ultimately led his surgical wound to reopen.

He had to undergo exploratory surgery in December 2016 in which cultures identified the presence of mycobacteria, the complaint says. The lawsuit alleges that he has suffered excruciating pain, weakness, and other problems directly as a result of the defendants’ defective device.

The Heart Surgery Complications Lawsuit is Case No. 3:18-cv-02892-S in the U.S. District Court for the Northern District of Texas.