Contaminated medical devices used in open heart surgery caused severe infection in patients

Paul Johnson always knew he'd need surgery on his heart after doctors discovered a defect in his aortic valve when he was 15 years old. In October 2015, at the age of 62, he finally had that procedure at the Mazankowski Heart Institute in Edmonton. 

Now, the 68-year-old sits in constant pain, unable to move freely around his house on his own. He takes a cocktail of antibiotics and painkillers every day, and his wife, Cathy Johnson, has become his full-time caregiver. 

During that open heart surgery in 2015, Johnson was exposed to a slow-growing bacteria, called M. chimaera, that has ravaged his body. 

"The hardest thing is seeing somebody you love in a lot of pain and not being able to do the things that they want to do in life," said Cathy.

Johnson is part of a class-action lawsuit that was launched because contaminated medical devices used in open heart surgeries led to serious, and in some cases deadly, M. chimaera infections.

Approximately a dozen former patients with confirmed infections or their families are part of the suit against LivaNova, formerly known as Sorin, the manufacturers of the Sorin 3T Heater-Cooler System, a medical device used to regulate the temperature of fluids during open heart surgeries. 

The water tanks on the Sorin 3T Heater-Cooler System were contaminated with M. chimaera at the manufacturing facility in Germany, according to the lawsuit, which has been certified by an Ontario Superior Court judge.

M. chimaera is a common bacteria found in the environment, in soil and water. Although it rarely leads to infection in humans, when it does, it can be deadly. 

"It's an incredibly serious infection,'' said Dr. Stephanie Smith, director of infection prevention and control at the University of Alberta. "The mortality [rate] is incredibly high."

The heater-cooler medical device, which is essential in open heart surgeries, did not come into contact with patients.

Instead, the lawsuit alleges, a fan on the machine aerosolized contaminated water from the device's tanks into the operating rooms. 

"[The bacteria] landed in the open chest of patients, or on some kind of prosthetic material that was being put into the patient at the time of their surgery," said Smith, who's part of the team overseeing the treatment of infected patients in Alberta. 

The number of M. chimaera infections related to the heater-cooler devices in Canada is unknown, although there are confirmed cases in Alberta, Ontario and Quebec. 

According to the lawsuit, the last device with a risk of contamination was pulled from service in July 2018, but symptoms can take up to five years before they begin to show.