The parents of a child who allegedly developed an infection after Fontan surgery have filed a medical device lawsuit against the maker of a cardiac heater-cooler.

The parents are suing LivaNova PLC and Sorin Group USA as a result of the use of the heater-cooler blanket during the surgery. According to the parents, in 2017, the child went through the Fontan Circulation Completion Procedure in New Orleans at Children’s Hospital. The parents and their child lived in Louisiana at the time that the child developed the infection.

A Stockert heater-cooler 3T thermo-regulator device was allegedly used to maintain the patient’s body temperature. Unfortunately, according to the infection after Fontan surgery lawsuit, the child developed serious complications and side effects directly related to the use of this heater-cooler blanket.

According to the lawsuit, the child developed “yellowish drainage to her surgical incision site, and she subsequently required treatment for mycobacterium abscessus.” The treatment of the infection after Fontan surgery required the child to be readmitted to the hospital for a months long stay before she recovered.

The Stockert 3T blanket was sold and marketed to hospitals throughout Louisiana. According to the infection after Fontan surgery lawsuit, the manufacturers of the heater-cooler blanket failed to warn hospitals about the dangers of developing life-threatening infections.

In 2005, a 510(k) pre-market notification of intent to market the Stockert 3T was sent to the Food and Drug Administration. The 510(k) program is a simplified application process for medical devices that does not require extensive approval and review by the FDA if the device being approved is substantially similar to a device already on the market. In 2016, the FDA decided that the Stockert 3T device was substantially equivalent to those already on the market.

According to the infection after Fontan surgery lawsuit, mycobacteria could easily be brought in through the heater-cooler blanket during a surgery, exposing patients who are subjected to this device to the possibility of developing a life-threatening infection. A 2014 report from a health professional indicated that at least one patient suffered from an infection after surgeries in which the Stockert 3T was used. The investigation carried out by the hospital identified bacteria in all of the Stockert 3T device tanks across the facility.

The parents claim that they were never told about the possibility of their child developing a life-threatening infection and should have been advised well in advance about the possibilities for this to impact the child’s life. If you or someone you know has already developed an infection after Fontan surgery, you could have grounds to pursue a lawsuit.

Going through heart surgery often requires that the patient’s body temperature be monitored and controlled carefully. As a result of the dangers surrounding these kinds of procedures, a heater-cooler blanket might be used to make temperature control easier. However, a number of people have developed life-threatening infections due to entrance of bacteria getting inside the device during the surgical procedure. The patient might not even realize the dangers until the infection has reached serious levels.

The Fontan Surgery Infection Lawsuit is Case No. 2:18-cv-06965-MVL-JVM, filed in the United States District Court, Eastern District of Louisiana.