Montreal Heart Institute files lawsuit against medical equipment maker

The Montreal Heart Institute has filed a $345,000 lawsuit over a piece of equipment that led the institute to contact thousands of patients because they might be at risk of bacterial infection.

The MHI contacted patients in 2016 after Consumer Reports magazine published an article about the device being linked to heart and lung infections.

The institute filed the lawsuit against the maker of the equipment — LivaNova Corporation — in Quebec Superior Court this week.

In the lawsuit, the MHI said it bought six of the machines — used to regulate a patient’s body temperature during certain operations — in 2007, and followed the manufacturer’s maintenance instructions.

In 2015, after LivaNova contacted the institute to warn of possible bacterial contamination, tests were done on the machines and they were found to be contaminated, the lawsuit says. The manufacturer’s new decontamination instructions were ineffective and the machines were replaced in 2016, the lawsuit said.

The MHI said it spent more than $200,000 contacting more than 8,000 patients to alert them to the possible danger. That doesn’t include the expenses incurred trying to decontaminate the equipment, nor does it include the cost of replacing LivaNova’s machines.

The lawsuit said LivaNova has refused all requests for compensation.

From Jan. 1, 2010 to Feb. 29, 2016, the U.S. Food and Drug Administration received 180 incident reports related to heatercooler devices around the world, Consumer Reports noted in 2016. Among the incidents were at least 45 American patients who later became infected and at least nine who died.

Those infected developed nontuberculosis mycobacteria (NTM), which is usually harmless, but if it makes its way into the chest cavity or onto a prosthetic heart valve of a surgical patient, it can turn fatal.

In 2016, the MHI said it had discovered that two patients out of 8,458 operated on since 2012 developed infections. The patients were undergoing treatment.

LivaNova, a medical technology company based in the United Kingdom, did not respond to a request for comment.