A man has filed suit against the manufactures of a cardiac heater-cooler after he allegedly suffered an infection following open heart surgery.

According to the heart surgery infection lawsuit, plaintiff Bernard P. is a resident and citizen of the state of Florida. He had undergone open heart cardiac surgery at the VA Ann Arbor Healthcare System in February 2017.

Durging that surgery, Bernard says, he was “exposed to a rare and potentially fatal bacteria via Sorin 3T Heater-Cooler Systems used to regulate body temperature.”

Bernard claims that the bacteria he was exposed to was mycobacterium avium complex (MAC) which is a “slow growing subset” of the nontuberculous mycobacterium (NTM) class. He tested positive for MAC in May 2015, and he says he must undergo a three-year course of antibiotics.

The heart surgery infection lawsuit further maintains that MAC puts patients at risk for infection after heart surgery. The bacteria, although it occurs naturally in the environment and rarely causes illness, will actually slowly grow within a patient once a patient becomes exposed to it.

It can purportedly take anywhere between several months to six years before symptoms of an infection appear.

By that time, time such an infection that has been slowly growing may cause a heart infection known as endocarditis. It can also cause a “disseminated infection,” which is an infection that occurs throughout the entire body.

Some of the symptoms of an M. Chimaera infection following open heart surgery may include any of the following: pain, night sweats, fever, unexplained weight loss and fatigue, and muscle and joint pain.

3T Heater-Cooler System Facts

The Sorin 3T Heater-Cooler System functions to regulate body temperature while a patient undergoes surgeries such as open heart surgery. Bernard’s complaint explains that the Sorin 3T “regulates blood temperature by circulating water through tubes into a heat exchanger where blood is pumped into separate chambers during surgery.”

The risk of an NTM infection arises due to contamination inside the heater-cooler system. If not properly sanitized and cleaned, an NTM culture can develop. Bacteria can be blown out the unit’s exhaust system and into the surrounding air in the operating room, where it can then find its way to the patient’s open surgical wound.

The Centers for Disease Control and Prevention issued an Interim Practical Guidance communication to healthcare departments and medical providers warning them of the risks involved in patients contracting an NTM infection.

The U.S. Food and Drug Administration has also received several MDRs, or Medical Device Reports, describing the complications and patient infections that have resulted from the use of a Sorin 3T system.

Bernard’s Heart Surgery Infection Lawsuit is Case No. 8:17-cv-02568-RAL-MAP, in the U.S. District Court for the Middle District of Florida, Tampa Division.