Two plaintiffs are bringing a Sorin 3T Heater-Cooler class action lawsuit against the maker of the cardiac heating and cooling system, LivaNova.

Plaintiffs Edward Baker and Jack Miller are filing this Sorin 3T Heater-Cooler class action lawsuit claiming that they were each exposed to nontuberculous mycobacterium during their respective heart surgeries at two different hospitals as a result of the Sorin 3T Heater-Cooler.

They seek to represent a class of individuals who have been adversely affected by the Sorin 3T Cardiac Heater-Cooler.

What is the Sorin 3T Heater-Cooler?

The Sorin 3T Heater-Cooler is a very important medical device that is used during heart surgeries. It helps keep organs and blood at the proper temperature during bypass surgeries.

Heater-cooler devices, like the Sorin 3T Heater-Cooler, consist of water tanks with temperature controlled water that do not contact patients directly.

However, the FDA reports that “there is potential for contaminated water to enter other parts of the device and aerosolize.”

This means that  bacteria can be transmitted in the air into the environment and to the patient.

These are very common devices. They are used by 250,000 heart surgery patients each year. Around 60% of those devices are currently in use have been connected with life-threatening infections.

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both issued warnings that claim the danger of these devices.

The FDA and CDC have reported that the Sorin 3T heater-cooler devices were allegedly contaminated with Mycobacterium chimaera, a bacteria, when they were manufactured in Germany.

During tests in Sept. 2014, M. chimaera contamination was discovered at the manufacturing facility for the Sorin 3T heater-cooler devices.

However, this problem was resolved the following year in July 2015 when the facility was tested again.

The FDA reports that because of this all-clear from the facility, 3T devices manufactured after September 2014 don’t have any link to the harmful bacteria.

However in June 2016 the FDA noted that the development of bacterial infections were linked to LivaNova 3T heater-cooler devices.

The CDC is encouraging heart surgery patients who are experiencing the following symptoms to seek medical attention as they may be linked to a bacterial infection:

• Night sweats
• Muscle aches
• Weight loss
• Fatigue
• Unexplained Fever

Plaintiffs File Sorin 3T Heater-Cooler Class Action Lawsuit

Both of the plaintiffs in this Sorin 3T Heater-Cooler class action lawsuit claim that LivaNova knew or should have known that the design and manufacturing defects of the heater-cooler system promoted bacterial colonization.

This bacteria, to which patients are exposed during surgery, can have life-altering or even deadly effects.

The plaintiffs are seeking medical monitoring to screen for the NTM infection.

They are also asking that, pursuant to the Federal Declaratory Judgment Act, the Sorin device should be declared defective and unsafe.

The Sorin 3T Heater-Cooler Class Action Lawsuit is Edward Baker and Jack Miller et al. v. LivaNova PLC, Case No. 1:16-cv- 00260 in the U.S. District Court for the Middle District of Pennsylvania.