
A growing number of heart surgery patients are reporting serious infections, allegedly due to contaminated heater-cooler devices used during surgery. These infections can be serious and even life-threatening.
Heater-cooler devices are used during heart surgeries to regulate a patient’s blood and organ temperature, warming and cooling it as needed.
It’s not just patients that are worried about the risk of infection. The Center for Disease Control has released a warning to consumers about these dangers, noting that during the manufacturing process, some devices became contaminated.
The CDC warned that patients undergoing heart surgery may be at risk from serious infections, most notably nontuberculous mycobacteria (NTM), from certain heater-cooler systems.
The CDC has also said that the “overall risk of [mycobaceria] infection is low relative to other complications following surgery,” affecting between one in 100 and one in 1,000 patients. Though it is a rare occurrence, infection from contaminated heater-cooler devices is a danger that can become fatal.
The Stöckert 3T Heater-Cooler, a device manufactured by LivaNova PLC, has been specifically implicated in the CDC’s warnings. Inspections at this device’s manufacturing facility in Germany have revealed the presence of mycobacteria.
Devices Could Be Source of NTM Infections
An NTM infection comes with several possible symptoms, including night sweats, aching muscles, joint pain, weight loss, fatigue, and fever. Symptoms of an NTM infection may remain dormant for quite some time instead of appearing right away, and they may take months to surface after the initial infection.
This extended amount of time between infection and when a patient starts exhibiting symptoms often means that patients have no idea what caused the problem in the first place, leading to a delayed diagnosis for months or even years.
Fortunately, NTM is not a contagious disease, and can’t spread from person to person. However, it is a serious and life-threatening illness and in some cases, patients may have to go through over a year of recovery.
Both the CDC and the U.S. Food and Drug Administration have published alerts about the dangers of contaminated heater-cooler device systems. The FDA has provided hospitals with instructions on how to deal with the risk of infection posed by these devices.
Litigation over Contaminated Heater-Cooler Devices
A LivaNova class action lawsuit over contaminated heater-cooler devices was filed in February 2016 in Pennsylvania. The patients involved in that action had undergone open heart surgeries in 2015 and since experienced dangerous infection symptoms.
If you or someone you love has suffered from a NTM infection after undergoing heart surgery with the use of a heater-cooler device and believe that contaminated heater-cooler devices may have been the cause, you may have grounds for taking legal action. A consultation with a knowledgeable attorney can apprise you of all your legal options.
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