Allegedly Non-Sterile Medical Equipment Used at Five British Columbia Hospitals, Class Action Lawsuit Certified

A class action lawsuit alleging that a piece of medical equipment used in heart surgeries is non-sterile names five British Columbia hospitals as having used the piece of equipment.

The class action lawsuit alleging that the Sorin 3T Heater-Cooler system, used during open-chest cardiac surgery at 35 Canadian hospitals, is non-sterile was certified by an Ontario Superior Court judge earlier this month.

According to the claim, BC Children’s Hospital in Vancouver; Kelowna General Hospital in Kelowna; Royal Columbian Hospital in New Westminster; Royal Jubilee Hospital in Victoria; and St. Paul’s Hospital in Vancouver all used the device up until 2017 or 2018.

In the class action lawsuit, lead Plaintiff Bruno Nardi alleges that Sorin Group Deutschland GMBH, the maker of the device, and Livanova Canada Corp. were negligent in the design, manufacturing, testing, distribution, and sale of the heater-cooler system, Castanet reports.

Nardi also says that the device may have led to the exposure of Mycobacterium Chimera, causing symptoms in patients years after their procedures. Health Canada says that the bacteria can cause invasive diseases and hard to treat infections that can require long-term treatment with antimicrobials.

The Sorin 3T Heater-Cooler systems are used in operating rooms during procedures where a patient’s blood temperature needs to be controlled, CTV News reports.

The device provides heated or cooled water to a heart-lung machine, which regulates the patient’s fluids that are circulating through the machine during cardiac surgery. According to federal health officials the devices are considered non-sterile.

In the certification hearing, Justice Paul Perell said the class action lawsuit met all five criteria for certification. The case will proceed.

In 2019, a lawsuit filed in the U.S. alleged that an Ohio resident died as a result of an infection that he contracted because of the use of a Sorin 3T Heater-Cooler System used during his heart bypass procedure. The claim alleged that a problem with the device’s design allowed bacteria to enter the decedent’s body during his operation.

Have you or anyone in your family had to use a heater-cooler device? Let us know your experience in the comments section!

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