The parents of a minor child who developed an M. chimaera infection after open heart surgery have filed a lawsuit against the maker of a heater cooler device.

LivaNova (formerly Sorin Group Deutschland) makes the Stockert 3T heater cooler device in Germany. These particular units have been linked to a rare and sometimes deadly bacteria called Mycobaterium chimera, also known as M. chimaera, that have allegedly invaded the bodies of patients during open heart surgeries.

An M. chimaera infection can be serious, and even deadly.

The heater-cooler device uses water to regulate the temperature of the body’s organs and blood during surgery. No water comes into contact with the patient, but the device emits a mist that enters the air and can settle into the open chest cavity. Any present bacteria is then sealed inside the patient once the patient is sewn back together. The bacteria can grow slowly for months or years.

The M. Chimaera Infection Traced to Germany

Researchers conducted tests and found the same exact strain of bacteria that was causing the M. chimaera infection in patients had also contaminated the production and servicing centers in Germany. Even though the bacteria is found naturally in soil and water, it remains a mystery as to how the bacteria entered the manufacturing areas and eventually contaminated the heater cooler units.

By October 2015, the FDA had received 32 reports of patients developing a rare infection at the surgical site after a heater-cooler device had been used during open-heart surgery. The FDA determined the infections were linked to the use of Stockert 3T heater coolers in June 2016.

In October 2016, the Center for Disease Control and Prevention released a warning to hospitals that the Stockert 3T posed a risk of M. chimaera infection.

The FDA says “there is potential for contaminated water to enter other parts of the device and aerosolize,” and the bacteria-laced mist can fall into the patient’s open chest cavity.

Child Developed M. Chimaera Infection

According to the M. chimaera infection lawsuit, a minor child became infected with the bacteria during an open-heart surgery performed in July 2017. Since then, the child allegedly has been treated for an M. chimaera infection purportedly caused by the use of a Stockert 3T heater cooler device used during the surgery.

The child’s parents have filed suit alleging LivaNova failed to warn of the dangers of using the Stockert 3T and failing to ensure the exhaust did not emit in a way that could cause an infection. The parents also allege the Stockert 3T device is made with an inadequate design and that the company failed to manufacture the devices in way that would avoid an unreasonable risk of harm.

They allege their child has suffered prolonged pain and suffering, permanent scarring, permanent impairment, mental anguish, medical expenses and treatments and loss of enjoyment of life, among other injuries.

The M. Chimaera Infection Lawsuit is Case No. 2:18-cv-04588-NJB-JVM in the U.S. District Court for the Eastern District of Louisiana.