LivaNova PLC is facing a new cardiac heater cooler lawsuit that was filed by a couple from Louisiana, alleging their child developed an infection after open-heart surgery.

The angry couple alleges their son’s infection developed soon after his open-heart surgery, which put the child’s life in jeopardy. Infection after open-heart surgerycan be potentially deadly to adults, which multiplies the risk if an infant is the patient in question.

Plaintiff couple Keith F. and Shelly F. filed this claim on behalf of their son, who had to undergo surgery soon after he was born. They allege the Stockert 3T Cardiac Heater Cooler System was used in the procedure.

Heater-Cooler Devices

The Stockert Cardiac Heater Cooler System consists of two temperature controlled water tanks that work to stabilize the patient’s body temperature during surgery. The water does not make direct contact with the patient but is used to transfer heat through other equipment.

These devices are considered very important in the medical field, because they keep the patient’s organs and body temperature under control during open heart surgeries and bypass procedures. These devices, however, have been recently linked to deadly mycobacterium chimaera (M. chimaera) infections, which can be potentially deadly to patients.

This was allegedly the case with the couple’s son, who had to undergo open-heart surgery soon after he was born on Aug. 3, 2017. According to the cardiac heater cooler lawsuit, the Stockert 3T Heater Cooler System was used for typical purposes during the surgery and was supposed to help the patient remain stable during the procedure.

However, the child reportedly developed an infection after open-heart surgery and has been contending with the recovery process. Keith and Shelly opted to file legal action against LivaNova after discovering that other patients suffered similar experiences and learned of several public warnings from the FDA and CDC.

Overview of Cardiac Heater Cooler Infection

The FDA and CDC recently stated that Stockert 3T Heater Cooler Devices that were manufactured at a specific plant in Germany before September 2014 may have been have been contaminated with the M. chimaera bacteria.

This bacterium is often found in water or soil, but can be potentially deadly if they come in contact with an open surgical wound. This contamination issue was reportedly resolved in July 2015 when the facility was tested again, and devices manufactured after September 2014 should be free of contamination.

While the water tanks of the heater cooler device do not directly touch the patient, the contaminated water could become aerosolized through the device’s exhaust system. This allows the bacteria to be released into the air and make contact with the open surgical area.

These bacterial infections have been reported in Iowa, Michigan, and Pennsylvania since 2011 to the present date; the CDC stated that there has been a total of 28 confirmed M. chimaera bacterial infections.

The FDA further noted that at least 12 patients may have died due to this infection. The FDA warned that M. chimaera bacterial infections are rare, but infection after open-heart surgery can develop months to years after the procedure. Symptoms of M. chimaera infection after open-heart surgery includes:

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

Even though M. chimaera bacterial infections can be potentially deadly, the parents say LivaNova allegedly failed to warn the public in a timely manner.

This Cardiac Heater Cooler Infection Lawsuit is Case No. 2:18-cv-07240-LMA-DEK, filed in the U.S. District Court of Eastern Louisiana.