An Iowa state resident, plaintiff Terrance S., has filed a products liability lawsuit in Iowa federal court purporting that he had developed a bacterial infection after undergoing heart surgery.

According to the heater cooler bacterial infection lawsuit, Terrance underwent open-chest cardiovascular surgery at Mayo Clinic in Rochester, Minn. in February 2015.

The heater cooler bacterial infection lawsuit contends that “during the procedure, the Stockert 3T (‘3T System’) heater-cooler system was used, exposing him to Mycobacterium avium and Mycobacterium Chimaera infection.”

Defendants Sorin Group Deutschland GMBH and Sorin Group USA Inc. are the manufacturers, marketers, and sellers of the 3T system used as thermal regulation devices in operating rooms throughout the country.

According to the heater cooler bacterial infection lawsuit, the 3T System, “is intended to provide temperature-controlled water to heat exchanger devices to warm or cool a patient during a surgical procedure such as the plaintiff’s in this case.”

The heater cooler unit and 3T system is used to regulate a patient’s body temperature during open heart surgery or any other invasive surgical procedure. It is used to keep the blood flow well circulated and helps keep the body’s organs at a safe temperature.

The 3T system works by storing water in a tank. The tank can then either increase or decrease a patient’s body temperature by keeping the water at a specific temperature.

According to the heater cooler bacterial infection lawsuit, the inside of the heater cooler unit can become contaminated with bacteria if it is not adequately cleaned and maintained. The bacterium at issue is Mycobacterium chimaera, “a subspecies of nontuberculous mycobacterium (‘NTM’).”

CDC Warns of Infection from Open Heart Surgery

In October 2016, the Centers for Disease Control and Prevention (CDC) sent a notice to hospitals throughout the country, advising that the 3T system was “potentially contaminated with bacteria, putting patients at risk for a life-threatening infection,” Terrance says.

The heater cooler bacterial infection lawsuit iterates that the announcement had identified more than 17,000 patients and had also assembled a crisis management team. They had identified these patients that had undergone cardiac surgery within the last five years, and “sent letters to each of the patients advising them of the recently discovered risk of infection.”

According to heater cooler bacterial infection lawsuit, Terrance is the one patient confirmed to have been diagnosed with the bacterial infection.

Terrance further alleges that the FDA had issued a Class II recall of the 3T System in July 2015, due to the “potential colonization of organisms, including Mycobacteria, in the 3T System devices, if proper disinfection and maintenance is not performed per instructions for use.”

The Heater Cooler Bacterial Infection Lawsuit is Case No. 3:17-cv-03058-LTS, in the U.S. District Court for the Norther District of Iowa, Central Division.