A Georgia couple has filed a lawsuit against medical device company LivaNova, claiming that one of their contaminated heater-cooler devices was the reason behind the husband’s severe bacterial infection.

Plaintiffs Robert S. and Meloney S. allege that one of LivaNova’s contaminated heater-cooler devices was used during Robert’s coronary artery bypass surgery in 2014.

This device was a 3T Heater-Cooler System. A heater-cooler system is often used in cardiac surgeries to help regulate the blood temperature of the patient. Regulation of blood temperature aids in recovery and provides the best possible environment for the success of the surgery.

In a cardiac heater-cooler system, temperature-controlled water helps keep the temperature of the patient’s blood at an ideal level.

Critics claim that some contaminated heater-cooler devices have a strain of bacteria present in the water. When this water is aerosolized, it can be released into the sterile operating room and come into contact with an open wound of a patient.

After Robert’s surgery in April 2014, he was later re-admitted to the hospital that September after he complained of wheezing and gurgling in his chest. He was tested for infection and the blood cultures came back negative, according to this contaminated heater-cooler devices lawsuit.

The following year, in December 2015, the plaintiff went to the emergency room for multiple symptoms including rib pain, abdominal pain, epigastric pain, body ache, cough and shortness of breath. The doctors gave him antibiotics and steroids before they released him.

Less than one year later, in August 2016, Robert was treated at the emergency room for severe chest pain and abdominal pain. He was also experiencing drainage from the incision site from his bypass surgery from two years previous.

This contaminated heater-cooler devices lawsuit reports that Robert was then diagnosed with chest wall pain and infection. The doctors began him on a course of Bactrim.

Over the course of the next month, Robert experienced worsening symptoms. He was readmitted to the hospital for signs of an infection including chest pain and drainage at his wound site. He underwent a CT scan and blood cultures.

Signs of bone infection at the sternal wound site were present after the tests Robert underwent.

Robert was then transferred to another hospital for a higher level of treatment at which place he saw an infectious disease specialist. The specialist discovered that Robert had contracted Mycobacterium chimera, a strain of NTM, or nontuberculous mycobacteria. This NTM bacteria has been linked to contaminated heater-cooler devices made by LivaNova.

NTM bacteria is normally found in soil and not present in humans.

Because of Robert’s infection, he was put on a six-week course of IV antibiotics and confined to his home to recover. In the following months, he underwent two more surgeries, aggressive antibiotic treatment and still suffers from the NTM infection and associated complications.

Through all of this, it was discovered the NTM bacteria was present in one of the contaminated heater-cooler devices at the hospital in which he underwent his original surgery, the plaintiffs claim.

Robert and Meloney allege that it is the fault of the device manufacturer that he suffers from the loss of enjoyment of life, mental anguish, physical pain and permanent impairing and scarring.

This Contaminated Heater-Cooler Devices Lawsuit is Case No. 2:17-cv-00124-RWS in the United States District Court for the Northern District of Georgia, Gainesville Division.