Patients who have had open-chest surgery and subsequently suffered from serious bacterial infections are filing lawsuits against LivaNova PLC (formerly Sorin Group Deutschland GmbH), the manufacturer responsible for the Stockert 3T Heater-Cooler System. New studies indicate that the Stockert 3T devices were likely contaminated during the manufacturing process with the rare bacteria called Mycobacterium chimaera (M. chimaera).
Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention have advised medical facilities to notify patients who underwent open-chest surgery involving a Stockert 3T Heater-Cooler that the device was possibly contaminated and could potentially put patients at risk of a life threatening infection.
On June 15, 2015, the Sorin Group issued a recall of the 3T device, stating that there was “potential colonization of organisms, including Mycobacteria if proper disinfection and maintenance is not performed per instructions for use.” And, on October 13, 2016, the FDA issued an updated safety alert indicating that research corroborates that the M. chimaera bacteria found in infected patients matched samples taken from the Stockert 3T device from hospitals in geographic distinct regions around the United States.
The Stockert 3T System
The Stockert 3T Heater-Cooler System is a common device used during invasive surgeries (such as open-chest cardiac procedures involving the heart, lungs, and other organs) that uses water tanks to warm or cool patients during surgical procedures. However, the system’s tanks can become contaminated with bacteria which can come in contact with patients when it is emitted as a vapor into the sterile surgical room.
It can take months or even years for patients to develop infections from M. chimaera exposure. Potentially exposed patients should seek medical care if they are experiencing symptoms such as night sweats, muscle aches, unexplained weight loss, fatigue, or unexplained fever.
The potential scope of these infections is massive when you consider that there a more than 250,000 heart bypass procedures using heater-cooler devices performed in the United States every year.
Among other legal claims, the allegations against LivaNova include: faulty device design that causes bacterial colonization, failing to conduct adequate testing, failing to provide proper cleaning and disinfection procedures and failing to warn hospitals and doctors of the potentially life-threatening infection when the device is used during cardiothoracic surgeries.
Patients who have undergone cardiac surgery should look for potential symptoms and complications (e.g., fever of undetermined origin, night sweats, joint pain, and weight loss) from nontuberculous mycobacteria infections that can occur up to several years after surgery. If you experience any of the above symptoms, it’s crucial that you notify your treating physician that you might have a nontuberculous mycobacteria infection and that special cultures and molecular diagnostics need to be performed to help diagnose and treat this serious condition.
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If you have had an open chest procedure involving the heart, lungs, and other organs and are now experiencing the above symptoms you may have been exposed to the M. chimaera bacteria. The lawyers at Paglialunga & Harris, PS are providing free consultations and claim evaluation for individuals throughout the United States. Call now.