A couple from Texas has filed a cardiac surgery infection lawsuit against the makers of a medical device that they claim led to the husband’s contraction of a rare infection after heart surgery.

Plaintiffs Richard K. and Margaret K. claim that when Richard went in for heart surgery, he developed a cardiac surgery infection. They also claim that he developed that infection because medical professionals used a device known as a cardiac heater-cooler that was contaminated with bacteria.

What is a Cardiac Heater Cooler?

A cardiac heater cooler is a device that is used during open chest surgery to help regulate the temperature of patients. The use of such a device helps keep the patient at an optimal temperature to aid in recovery time and improve the outcome of the surgery.

The device delivers temperature-controlled water to cool or heat other surgical instruments. Water in the device never comes into contact with patients. However, when research was done at a manufacturing plant for cardiac heater cooler devices, inspectors discovered a form of bacteria normally found in soil and water that could be contaminating the devices.

The device in question is the Sorin 3T Heater Cooler system manufactured by LivaNova. The bacteria that can live inside the devices that potentially cause cardiac surgery infection is called M. chimaera. 

M. chimaera is a form of non-tuberculous mycobacterium bacteria that can be dangerous to humans if they are exposed to it. Normally, humans are not at risk for infection when exposed to M. chimaera. However, when bacteria inside the machine are aerosolized into the air of operating rooms, the bacteria can find their way to infect patients.

According to Richard and Margaret’s cardiac surgery infection lawsuit, Richard was admitted to Baylor University Medical Center for several conditions including mitral valve replacement, ventral hernia repair, and resection of anterior mitral valve leaflet.

This occurred on June 9, 2016. Several weeks later, on July 21, 2016, he was allegedly readmitted for an incisional cardiac surgery infection and underwent a debridement procedure on July 22, 2016.

He alleges that his cardiac surgery infection was a direct result of contamination from the heater cooler device used during his surgery.

The couple is holding the manufacturers liable for design defect and manufacturing defect. The cardiac surgery infection lawsuit alleges, “The failure to use feasible, reasonable alternative designs that eliminate bacterial colonization and the aerosolization of bacteria into the ambient air of operating rooms renders the 3T unreasonably unsafe.”

They claim that the device manufacturers knew or should have known that there was a risk of cardiac surgery infection because of the contamination of their devices. They also claim that the manufacturers failed to “provide proper cleaning and disinfection procedures for the 3T,” that they failed to “conduct proper validation studies to demonstrate the safety and efficacy of cleaning and disinfection procedures for the 3T” and that they did not warn patients of the possible risks of cardiac surgery infection.

CDC Health Alert Issued Over Heater Cooler Devices

The FDA and CDC stated Sorin 3T heater cooler devices manufactured before September 2014 may be contaminated with M. chimaera bacteria, and that the manufacturing facility reportedly resolved the issue by July 2015.

This means that if a hospital or other healthcare facility has a heater cooler manufactured before September 2014, they could put patients at risk for life-threatening post-surgical infections.

More specifically, the CDC stated patients who underwent open-heart surgery that utilized this device could be at risk for developing the M. chimaera bacteria infection.

It is important to note that this infection can strike months or even years after the surgery, with bacteria cultures reportedly taking up to eight weeks to grow in a lab before final identification. Symptoms of the M. chimaera bacterial infection include:

• Night Sweats
• Muscle Aches
• Unexplained Weight Loss
• Fatigue
• Unexplained Fever

M. chimaera infection has been reportedly linked to cases in Iowa, Michigan, and Pennsylvania from 2011 to present. According to the CDC there have been 28 confirmed infections, with the FDA stating that at least 12 patients have allegedly died from the infection.

The CDC currently estimates that the risk of bacterial infection from the M. chimaera in hospitals where at least one infection was identified was between one in 1,000. While the infection is rare, the FDA stated patients and doctors should still be vigilant for symptoms.

At this point in time, the allegedly contaminated 3T Sorin heater cooler devices have not been withdrawn from the market by LivaNova. The company did recall the instructions for the products in 2015.

According to the information provided by LivaNova, water from the device should not make contact with the patient and could introduce the risk of bacterial infection under certain conditions.

This Cardiac Surgery Infection Lawsuit is Case No. 4:18-cv-00533-A in the United States District Court for the Northern District of Texas.