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If you recently had open-heart surgery, you may have contracted an infection from the medical device that keeps your body warm during a surgical procedure.
The Stockert 3T Heater-Cooler System is a medical device that keeps your body temperature regulated during cardiac surgeries. The water tanks in the device can become contaminated with Mycobacterium chimaera either at the manufacturing plant where the device is developed or the hospital where the surgery occurs. The bacterium can cause Non-Tuberculous Mycobacterium (NTM) in patients with an open wound or poor immune systems. Numerous heater-cooler device lawsuits are currently being filed on behalf of those who contracted the potentially deadly infection.
February 2018 - Lawsuits from around the country were consolidated into a multidistrict litigation in Pennsylvania federal court.
July 11, 2017 - The FDA has issued a Medical Device Safety Communication update informing Stöckert 3T Heater-Cooler System users of the Mycobacterium chimaera infections associated with the medical device. The updates include further recommendations and precautionary steps for healthcare professionals to take in an effort to mitigate the potential risks associated with the device.
The update comes subsequent to claims that the 3T had caused patients to develop heart infections when the device was used during heart surgery. The infections are believed to be caused by the Mycobacterium chimaera which builds up in the interior of the machine where the patient's blood is exposed. As the blood leaves the machine and re-enters the body, the infectious bacteria spreads.
The Pennsylvania Department of Health, along with the CDC, conducted field investigations of the device which identified an association between the bacterial infection and exposure to contaminated 3T Heater-Cooler Systems.
The Stöckert 3T Heater-Cooler System, also known as the Sorin 3T Heater-Cooler System, is produced by LivaNova PLC. The device is used to control the temperature of a patient's blood and organs during cardiovascular procedures.
The device first came to market in 2006. Since that time there have been 32 Medical Device Reports filed by consumers to the FDA. The CDC has confirmed 28 infections of patients exposed to the device. Of the 28, at least 12 patients have died from bacterial infection according to the CDC.
An estimated 250,000 open-heart patients are exposed to the device, or similar devices, every year. Around 60% of the devices still currently in use have now been linked to Mycobacterium chimaera contamination. Symptoms of the bacterial infection may take time to develop and include night sweats, muscle aches, weight loss, fatigue, and fevers. Though rare, infections can be life-threatening.
Hospitals are now directly contacting patients who have been exposed to possibly contaminated devices. Because the symptoms of the infections can remain dormant for months to years, hospitals have been requested to follow-up with any patient exposed to this device since 2011. There are around one million U.S. patients who underwent heart surgery in that time-frame.
If you have had heart surgery at any point in the last decade you should contact your healthcare physician, even if you are not showing symptoms of infection.
March 2016 - 3T Heater-Cooler System patients filed a class action lawsuit against LivaNova PLC. The class action, which was filed in Pennsylvania, claims that the company was aware of the possible health risks to consumers, but failed to make these adverse risks aware to consumers or the medical professionals using the device. Multiple individual lawsuits have also been filed against LivaNova under the same allegations.
The Stockert 3T Heater-Cooler System is a medical device that regulates your body temperature during cardiac surgeries. Essential for life-saving surgeries, the device keeps circulating blood and organs at a constant temperature by heating and cooling the body during open-heart surgery.
In simple terms, the heater-cooler units keep your body at a constant temperature by providing temperature-controlled water to heat exchangers through closed circuits thus warming your body. The water never comes in contact with your body, but the three water tanks are potentially creating mycobacterium chimaera, a potentially deadly, but slow growing, bacterium to those with open wounds and low immune systems. Vapors exiting the device’s exhaust vent are polluting the air with bacterium could then enter the open wound during surgery.
Unfortunately, the source of the contamination can occur in two places – at the manufacturing plant and/or the hospital. The two potential contamination issues increase the risk of infection in patients.
The bacterium, commonly found in soil or water, is typically not harmful, but is slow growing and can cause infections in those undergoing surgery or suffering from a suppressed immune system.
Becoming available to the market in 2006, the device has been used in over 250,000 heart bypass surgeries throughout the United States. 60% of those surgeries used the Stockert 3T Heater-Cooler System.
The FDA has said that similar devices may also have the same design flaw as the Stockert 3T Heater-Cooler system that causes bacterium infections. The flaw relates to contamination during the manufacturing period.
Since 2010, about 79 cases of infection, including 12 deaths, caused by the use of the Stockert 3T Heater-Cooler System have been reported to the U.S. Food & Drug Administration. As a result, heater-cooler device lawsuit(s) are being filed across the country.
If you believe you may be suffering from adverse side effects due to a Stockert 3T Heater-Cooler System used during your open-heart surgery, please contact a medical professional right away.
If you believe you contracted an NTM infection during an open-heart surgery, please contact a knowledgeable attorney.
At TorHoerman Law firm, we have a dedicated team of Stockert 3T Heater-Cooler Device lawyers who will be here to help you every step of the way. Our firm is a nationwide products liability firm that wants to help those suffering from a personal injury due to dangerous medical devices.
Our firm works on a contingency basis meaning you do not pay us until the case has been won. If we lose, no money will come out of your pocket. This ensures we work as hard as we possibly can for each of our clients.
If you have any questions or would like to schedule a free, confidential consultation, please either fill out the consultation form to the left, call us at 618-656-4400, or email email@example.com.
October 2016 - The FDA updated its safety warnings to include the risk of developing a bacterial infection, known as Mycobacterium chimaera (M. chimaera).
Steps to prevent a bacterial chimaera infection, for both surgeons and patients, from occurring were also included in the warning.
June 2016 - The FDA released the first safety communication warning associated with the Stockert 3T Heater-Cooler System. The warning directly notified both patients and surgeons of infections linked to the devices.
December 29, 2015 - The FDA issued a warning to LivaNova PLC after inspections conducted at two manufacturing plants revealed significant issues and an increased possibility of contaminated heater cooler devices. The manufacturer recalled the instructions for use but did not recall the device itself.
August 2014 - The FDA became aware of an alert issued by LivaNova PLC, the manufacturer of the device, about the device's potential to cause patient infection after a surgical procedure and begins their own investigation.
May 2014 - Greenville Memorial, a South Carolina hospital asked state and federal investigators to investigate the link between the medical device and patients who developed an infection.
"Contaminated Heater-Cooler Devices." Healthcare-Associated Infections, Centers for Disease Control and Prevention, www.cdc.gov/hai/outbreaks/heater-cooler.html.
"FDA's Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices." U.S. Food and Drug Administration, U.S. Department of Health and Human Services, 28 Mar. 2017, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm.
Terhune, Chad, and Christina Jewett. "Deadly Infections Linked to Heart Surgery Device Highlight Holes in FDA Oversight." Kaiser Health News, Henry J. Kaiser Family Foundation, 30 Nov. 2016, www.scpr.org/news/2016/11/30/66678/deadly-infections-linked-to-heart-surgery-device-h/.
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