A heater cooler devices complaint has been filed by a woman who says she became ill after open heart surgery.

Plaintiff Wilma A. underwent heart surgery in April 2014. During the surgery, a Stockert 3T heater cooler device was used to maintain the temperature of her blood and internal organs.

The Stockert 3T was manufactured by LivaNova PLC, formerly Sorin Group Deutschland GmbH, and Sorin Group USA, Inc.

The heater cooler devices allegedly were contaminated with Mycobacterium chimaera, which can lead to serious illness or death. Manufactured in Germany, the Stockert 3T has been linked to patient deaths related to infections since January 2014, according to the FDA.

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.

Wilma says she developed “unexplained infection and symptoms consistent with the Mycobacterium chimaera and has required ongoing medical treatment” after her surgery.

Heater Cooler Devices Spread Airborne Contamination

The cardiac heater cooler devices use water to regulate temperature control, and even though the water does not come in contact with blood or organs, there is the possibility that evaporating water can send contaminates into the air. The device also has an exhaust vent that could send bacteria into the air.

When airborne, bacteria can land in the chest cavity during the operation and plant seeds of infection that can develop months or years after exposure.

According to the heater cooler devices lawsuit, “infections related to Mycobacterium chimaera develop over time with serious symptoms, including, but not limited to, night sweats, muscle aches, weight loss, fatigue, and unexplained fever.”

FDA and CDC Issue Warnings

In October 2015, the FDA issued its first safety communication regarding the heater cooler devices because the agency said 32 medical device reports alleging infections from the units had been reported.

In June 2016, the FDA recognized that the bacterial infections were linked to the heater cooler devices made in Germany.

In October 2016, the FDA recommended further warnings to health officials regarding the prevention of the spread of the infection. These recommendations include using new accessories, tubing and connectors with the devices, and directing the exhaust fan away from the patient.

The heater cooler devices lawsuit says that LivaNova “failed to provide adequate and appropriate warnings and instructions to the user of the Stockert 3T heater cooler device.”

The heater cooler devices complaint goes on to say that “as a direct and proximate result of the negligent conduct of the Defendant, Plaintiff suffered infection and injury, severe and permanent disabilities, suffered severe emotional pain and distress, incurred medical expenses and will incur future medical expenses, and has lost the enjoyment of her life.”

Wilma and the hospital that purchased the Stockert 3T relied upon LivaNova to use its skill and knowledge to design, test, manufacture and sell the heater cooler devices as a safe and effective product when used in the intended surgical setting. the claim states.

The Heater Cooler Devices Lawsuit is Case No. 1:17-cv-01916-WTL-MJD, in the U.S. District Court for the Southern District of Indiana, Indianapolis Division.