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A life-threatening bacterial infection has been linked to the Sorin Stockert 3T Heater Cooler system, a medical device used during heart surgery. In 2016, the FDA issued a release that the Sorin 3T System is associated with an increase in Mycobacterium chimaera and Nontuberculous mycobacterial infections after open heart surgery. These infections have led to successful lawsuits across the United States, as well as Florida. Have you or a family member undergone heart surgery since 2012? You might be entitled to compensation.
The Stockert 3T device is one of the most commonly used heater-cooler systems in medical facilities. It is used during surgery to help maintain a patient’s body temperature. Stockert 3T systems use water tanks to facilitate temperature control.
Heater-cooler devices are a vital part of maintaining patient care, especially during cardiothoracic procedures. They help regulate a patient’s organ and blood temperatures during these life saving open-heart surgeries.
According to the CDC, more than 250,000 heart surgeries depend on heater-cooler devices in the United States. About 60% of these surgeries have been linked to the Stockert 3T devices that are associated with the bacterial infections. Rightful lawsuits are being filed against the manufacturers of the 3T system for not taking the necessary precautions after the bacteria was found in their water tanks.
Lawsuits are being filed against the manufacturer of the Stockert 3T Heater-Cooler System, LivaNova PLC, for a number of reasons.
As far back as 2002, researchers in Germany found that the 3T water tank is a habitable environment for M. chimaera. For healthy patients, M. chimaera isn’t a lethal bacteria. However patients with compromised immune systems, like those undergoing heart surgery, are at a higher risk for developing an infection.
The researchers discovered that the contaminated water could escape the heater-cooler’s exhaust fan as a vapor and infect an otherwise sterile operating room, putting open heart patients at risk. Another study by Euro Surveillance, found evidence that the heater-coolers were already contaminated before leaving the manufacturing facility in Munich.
After finding out that their device was linked to dangerous contaminations, LivaNova PLC didn’t acknowledge the defect or warn hospitals and physicians about the dangers of the medical equipment.
Beyond not warning providers of the bacteria colonization, lawsuits also allege that LivaNova failed to:
Conduct quality safety tests on the machines
Properly sanitize and clean the 3T system on a routine basis
Warn patients about the risk of bacterial colonization
Warn hospitals and patients to seek tests for Nontuberculous mycobacterium after undergoing invasive surgery
When a manufacturer realizes that their device is potentially dangerous, it is their duty to warn the public and the FDA about the complications. LivaNova PLC did not warn the FDA and public in a timely manner, which is an act of negligence. The Stockert 3T heater cooler is responsible for countless infections and even wrongful deaths.
Symptoms for M. chimaera and Nontuberculous mycobacterium can take months or even years after heart surgery to become visible, which puts patients at a greater risk of more damage.
Patients who have undergone open heart surgery since 2012 using the medical device need to be made aware of the signs of these infections, in case they have been exposed to the bacteria.
The CDC advises doctors to stay in touch with their patients for further evaluation. Patients with prosthetic devices or valve implants are at an increased risk for developing an infections.
If you or someone in your family has undergone cardiac surgery and is experiencing symptoms associated with infections, you should seek medical attention immediately.
Symptoms of M. chimaera and Nontuberculous mycobacterial infections can take up to four years to become visible. After heart surgery, patients should monitor their health for these signs of infection:
Unexplained fever and night sweats
When infections have progressed, you also might experience abscesses, renal insufficiency, splenomegaly, pancytopenia, osteomyletis, or other signs of organ dysfuntion. If you’re experiencing any of these symptoms or any change in health, you should let your physician know immediately that you might have Nontuberculous mycobacterial infection. During your appointment, it is important that special cultures are taken to detect and treat the infection.
If you or someone you love has had a surgery using a 3T heater-cooler device, you could be eligible for compensation in a lawsuit against LivaNova or your medical provider. Depending on the severity of your case, you could be compensated for:
Lost wages during hospital stays and treatment appointments
Medical bills resulting from complications
Pain and suffering caused by the infection, medical treatments, and recovery timeline
Economic damages from your injury
Emotional distress and loss of enjoyment of life
Successful injury lawsuits are anchored in the idea of negligence. Negligence happens when a person, group, or employer acts recklessly, causing harm to another person. Frank Eidson, P.A. will help establish negligence in the following ways:
by showing that the Stockert 3T manufacturers or your medical provider had legal responsibility for your safety during surgery,
that the Stockert 3T manufacturers or your medical provider failed to fulfill their legal duty through inaction,
by showing that you were emotionally or physically harmed as a result.
If you or a family member has suffered from a bacterial infection after heart surgery using a Sorin Stockert 3T heater-cooler system, Frank Eidson can help you receive fair compensation.
Attorney Frank Eidson has successfully helped countless clients across Florida claim large settlements and reclaim their lives. From workers’ compensation settlements to personal injury and defective drug cases, Frank Eidson is dedicated to ensuring all of his clients receive the settlements they deserve in their negligence cases. Call Frank M. Eidson, P.A. today for a free case review at 407-890-0800.
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