Stockert 3T Heater-Cooler SystemDevice Can Lead to Bacterial Infection

Stockert 3T Heater-Cooler System

If you or a loved one underwent open-heart surgery that called for the use of a Stockert 3T and subsequently suffered injuries related to bacterial exposure, you may be entitled to compensation through a Stockert 3T Heater-Cooler Device lawsuit. Contact a Stockert 3T Heater-Cooler Device lawyer from TorHoerman Law for a free, no-obligation case consultation or use our chatbot below to get and instant online case evaluation to find out if you qualify for a Stockert 3T lawsuit right now.

 

 

What is the Stockert 3T Heater-Cooler System?

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.

 

Stokcert 3T Heater-Cooler Contamination

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, Stockert 3T heater-cooler device lawsuits are being filed across the country on behalf of those who have suffered injuries resulting from contamination.

 

Stockert 3T Heater-Cooler Device Injuries

Stockert 3T Heater-Cooler device injuries that qualify for the lawsuit include:

 

What is Non-Tuberculous Mycobacterium (NTM)?

NTM infections caused by the mycobacterium chimaera bacterium can be deadly to those recovering from surgery situations where the immune system is not as strong. The bacterium enters the air through the contaminated medical device and enters the open wound. Detection of the infection often doesn’t occur until months or even years after the surgery, and as a result, can be difficult to discover.

 

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.

 

 

Do I Qualify for a Stockert 3T Heater-Cooler Device Lawsuit?

If you under open-heart surgery that called for the use of a 3T and you subsequently developed injuries related to Non-tuberculous Mycobacterium (NTM), you may qualify for a Stockert 3T Heater-Cooler Device lawsuit.

Contact TorHoerman Law for a free, no-obligation case consultation or use our chatbot below to find out if you qualify instantly.

 

 

Filing a Stockert 3T Heater-Cooler Device Lawsuit

The first step to filing a heater-cooler lawsuit is mitigation – this means seeking proper medical treatment for your injuries right away, following your doctor’s orders and minimizing the costs associated with your injury.

Next, you should familiarize yourself with the civil litigation process so you know what to expect of your Stockert 3T lawsuit.

Then, you should contact a Stockert 3T Heater-Cooler injury lawyer to act as your representative. Your state statute of limitations bars the amount of time you have to take legal action after your injury, so do not hesitate to intitiate this process.

 

 

Hiring a Stockert 3T Heater-Cooler Injury Lawyer

Hiring a personal injury lawyer to represent you is one of the most important steps in the process of your Stockert 3T lawsuit. Find an attorney that is experienced, has the resources to litigate your case, and is dedicated to making sure you get the best outcome possible from your lawsuit.

Your Stockert 3T Heater-Cooler Injury lawyer will work to gather evidence to prove that liability for your damages falls on the manufacturer, Stockert 3T.

Your lawyer will build an argument to support this claim, with the hopes of gaining compensation for your losses.

Your Stockert 3T Heater-Cooler injury lawyer will navigate the complexities of the legal system and act on your behalf while you focus on the most important aspect of the whole process, getting better.

 

 

TorHoerman Law, Stockert 3T Heater-Cooler Device Lawyers

If you believe you contracted an NTM infection during open-heart surgery, please contact a knowledgeable attorney from our firm.

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 contact us or use the chatbot below to get an instant online case evaluation, free of charge.

 

 

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Stockert 3T Heater-Cooler Device Lawsuit | Heater-Cooler Device Lawyer
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Litigation Updates

CASE UPDATE: Lawsuits Consolidated into MDL

February 2018 - Lawsuits from around the country were consolidated into multidistrict litigation in Pennsylvania federal court.

Class Action Lawsuit Filed

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.

 

Medical Device Safety Update: Stöckert 3T Heater-Cooler System

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.

Safety Warnings Updated by FDA

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.

 

Safety Communication Warning Released

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.

 

FDA Issued Warning to Manufacturer

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.

 

FDA Became Aware of Alert Issued by Manufacturer

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.

 

Hospital Asked for Investigation into Link between Device and Infection

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.

See More

References

"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/.

Last Modified: October 6th, 2020 @ 03:42 pm

What is the Stockert 3T Heater-Cooler System?

The Stockert 3T Heater-Cooler System is a medical device that regulates your body temperature during cardiac surgeries. 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. However, the water tanks are potentially creating mycobacterium chimaera, a potentially deadly, bacterium to those with open wounds and low immune systems. This contamination can occur at the manufacturing plant or in the hospital. These two potential contamination issues increase the risk of infection in patients. A Stockert 3T Heater-Cooler lawsuit is filed on behalf of patients who used the device during surgery and subsequently developed injuries related to this contamination.