A couple has filed suit against the makers of a heart surgery device they say gave the man an infection.

At issue is the Sorin 3T Heater-Cooler System that was used when Earl G. underwent a coronary artery bypass grafting procedure. He claims the unit exposed him to nontuberculosis mycobacteria in February 2013.

The heart surgery device is used to maintain a normal blood temperature during open heart surgeries.

Approximately three months after his surgery, Earl started to experience pain, swelling, tenderness and drainage from the incision site. He also saw a lump had developed near the incision.

Earl was re-admitted to the hospital mid-May of 2013 to undergo a sternal wound debridement and washout procedure. He was then placed on antibiotics.

When doctors cultured the infection, they determined it was a mycobacterium colony-abscessus infection, but doctors were unsure of the bacteria’s source. To combat the infection, Earl had to undergo “numerous additional surgical procedures, medical management, and an extensive course of antibiotic therapy.”

Heart Surgery Device Defects Uncovered

The Sorin 3T Heater-Cooler System is also known as the Stockert 3T Heater-Cooler System and is made by LivaNova PLC, formerly Sorin Group Deutschland.

The heart surgery devices allegedly were contaminated with mycobacterium chimaera, which can lead to serious illness or death. Manufactured in Germany, the cardiac heater-cooler unit has been linked to patient deaths related to infections since January 2014, according to the FDA.

Independent tests have concluded that the strain of bacteria found in the machines is the same as that found in environmental samples from the production and servicing facility in Germany.

Problems with Heart Surgery Device Linked to Airborne Contaminants

The cardiac heater-cooler unit helps keep a patient’s organs and circulating blood at the correct temperature during an operation. The cardiac heater-cooler uses water to regulate temperature control of a patient’s organs and circulating blood.

Although the water does not come in contact with blood or organs, there is the possibility that evaporating water can send contaminants into the air. The heart surgery device also has an exhaust vent that could send bacteria into the air.

Any airborne bacteria could land in the chest cavity during the open heart surgery and plant seeds of infection that can develop months or years after exposure.

The heart surgery devices are used during 250,000 open-heart bypass surgeries every year. Nearly 60 percent of those machines are the German-made models that have been linked to possible deadly infections since 2006.

FDA Warns Doctors to Take Extra Precautions

The FDA issued a class II recall of the Sorin 3T System in July 2015 due to the “potential colonization of organisms, including mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per instructions for use.”

According to the heart surgery device lawsuit, “Contrary to the defendants’ representations and marketing to the FDA, the medical community and to the patients themselves, defendants’ Sorin 3T System has high injury and complication rates, fails to perform as intended, requires patients to undergo additional operations, and has caused severe and sometimes irreversible injuries, conditions, and damages to a significant number of patients, including the plaintiffs, all of which are violations of federal and South Carolina state rules and regulations.”

The FDA alerted health officials to take even more precautions in a warning released in October 2016. These recommendations include using new accessories, tubing and connectors with the devices as well as directing the exhaust fan away from the patient.

If you or someone you know developed an infection after open-heart surgery during which a heater-cooler heart surgery device was used, you could be eligible for compensation from the manufacturer.

The Heart Surgery Device Lawsuit is Case No. 6:16-cv-03132, filed in the U.S. District Court for the District of South Carolina, Greenville Division.