Plaintiffs Jon and Lynne S. file a lawsuit against the manufacturers of a cardiac heater cooler device, LivaNova Deutschland GMBH, in Colorado federal court.

Jon files the lawsuit purporting that he received a heart operation infection during his hospital stay from the cardiac heater cooler unit manufactured by the defendant.

According to the heart operation infection lawsuit, Jon is a resident of the state of Washington. LivaNova Deutschland GMBH is a foreign company headquartered in Munich, Germany. Its companies – LivaNova and LivaNova PLC – are in the U.S. due to contracts they have in the United States.

Jon and his wife were former Florida residents, where his open heart procedure took place. According to the heart operation infection lawsuit, Jon had undergone open-heart surgery in February 2014. It was there the 3T Heater-Cooler System was used to maintain his body temperature during surgery at Morton Plant Hospital in Clearwater, Fla.

After the surgery, Jon was discharged home. Later in the year, however, the heart operation infection lawsuit maintains that during his follow-up appointment his surgeon reported that his sternal incision had “become increasingly red since his surgery.”

He was readmitted to Morton Plant Hospital thereafter, as  he was sent there to undergo an incision and debridement surgery. There he had his sternal wires removed and received a wound vac during surgery.

However, after being discharged and home for eleven days, he then returned due to recurrent fevers, chills, and chest pain. The heart operation infection lawsuit reports that his wound was “warm and erythematous.” However, he still had the wound vac and had continued receiving antibiotics.

He had to be hospitalized for another 24 days. He was treated for his “chronic non-healing sternal wound and sternal wound infection.” He also received a second debridement surgery and his doctor removed the remaining sternal wires.

The heart operation infection lawsuit states that following surgery, he suffered chest discomfort and drainage from the wound. He then returned to the ER with a fever “after he developed a large amount of greenish, yellow fluid coming out of his sternal wound.”

Doctors reported that Jon had developed a nontuberculous mycobacteria infection.

The defendants face the following counts against them: Strict Liability- Design Defect, Strict Liability- Manufacturing Defect, Strict Liability- Warnings Defect, Negligence, Express Warranty, Implied Warranties, Fraudulent Concealment, Violation of Deceptive and Unfair Trade Practices Act, and Loss of Consortium.

Cardiac Heater Cooler Unit Facts

The current bacterial infection linked to the the heater cooler unit is a subspecies of NTM, or nontuberculous mycobacterium, M. abscessus.

The strain naturally occurs in the environment. When a heater-cooler unit becomes contaminated with this bacteria, it puts open-heart surgery patients at risk for NTM infection. Through patient surgeries, as open heart surgeries, chest cavities and organs can come into direct contact with the bacteria through the aerosolized water of the machine.

The heater cooler unit at issue is the Sorin 3T Heater-Cooler System by LivaNova. It was manufactured and designed to regulate body temperature through open heart surgeries or other invasive surgeries.

The Heart Operation Infection Lawsuit is Case No. 1:17-cv-02437-KLM, in the U.S. District Court for the District of Colorado.