A patient who had open heart surgery alleges that use of the Stockert 3T Heater Cooler device caused an infection that led to his stroke. He is now bringing a lawsuit against Stockert manufacturer Liva-Nova as well as Pennsylvania Presbyterian Medical Center, where he underwent the surgery in December of 2014, alleging that the hospital was negligent in failing to maintain and clean the device properly.
The patient, Ken Piechowski, underwent the surgery in order to replace a faulty heart valve. For five months, he seemed to be in perfect health. Then, in May of 2015, he began to suffer from overall weakness and unexplained fatigue. One day, his right leg suddenly became immobilized. After he was admitted to an emergency room, doctors discovered a number of blood clots around the aortic valve that had been replaced the previous December. Their diagnosis – endocarditis, a serious infection of the heart. Endocarditis is the result of bacteria entering the heart muscle, which then invade and infect damaged tissue within the heart lining.
In a related story, an outbreak of what is known as “Legionnaire’s Disease” has been attributed to the use of the Stockert 3T at the University of Washington Medical Center, where two patients died and three more became seriously ill. After testing all heater-cooler units in the hospital, it was discovered that all of them contained Legionella bacteria. This bacteria, also known as l.pneumophila, thrives in water tanks. Once infected, a patient with legionellosis (as it is also called) exhibits symptoms similar to those of pneumonia, including respiratory distress, cough and fever, muscular pain and headaches. It is fatal in approximately 10% of cases.
The bacteria that caused Piechowski’s condition is nontuberculous mycobacteria, or NTM. This is a very common type of bacteria to which people are exposed on a daily basis. Most of the time, NTM is relatively innocuous. However, for people who suffer from auto-immune disorder or undergo invasive surgery, exposure to NTM can result in serious, and even fatal infections. The incubation period for NTM is a lengthy one; in some cases, symptoms may not appear until four years after exposure.
Devices such as the Stockert 3T are regularly employed in order to stabilize a patient’s body temperature during major surgery. Approximately one-quarter million open heart procedures in the country employ the Stockert 3T. Lawsuits against Liva-Nova allege that the design of the Stockert 3T was faulty, preventing it from being properly cleaned between surgeries. Over the past year, at least 28 NTM infections have been linked to the use of the Stockert 3T, with several cases also being reported in the European Union.