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Infections after heart surgery lead to lawsuits

Controversial heater-cooler device Sorin T3

Every day, thousands of life-saving heart bypass surgeries are performed in the United States and most of them rely on a medical device used as a heater-cooler to maintain the appropriate body temperature of the patient.

One type of these devices, the Stӧckert 3T Heater-Cooler System manufactured by Sorin Group Deutschland GmbH (Sorin T3), has been at the center of a controversy due to claims of being associated with Mycobacterium chimaera (M. chimaera) infections in patients who had cardiothoracic surgeries.

The Centers for Disease Control and Prevention (CDC) reports more than 250,000 heart bypass procedures using heater-cooler devices are performed every year.

Information on infections related to heart surgery

This medical equipment works with tanks to provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. They are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes, according to the Food & Drug Administration (FDA).

M. chimaera Infections potentially deadly

M. chimaera is the short abbreviation for a type of nontuberculous mycobacterium (NTM), in short a type of bacteria that can cause severe illness and even death. Most people when exposed to a dangerous bacteria begin to feel symptoms within days. Our body and our immune system are alerted to the presence of something harmful and begins to take action. Unfortunately, with this type of bacterial infection the symptoms lay latent for sometimes years after initial exposure, in some cases up to 3 years-5 years afterwards.

Without question exposure to this bacteria long term without treatment could result in death. Many who were infected also either had to undergo an additional surgery or a prolonged treatment (sometimes up to a year) of additional antibiotics.

Sources: FDA Communication, CDC Communication, NSW (a government authority in Australia) notice regarding infections post heart surgery. 

Behind the issues with the Sorin T3

Late in 2015, the FDA released its first public safety warning on the Sorin T3 after reports of infections due to the way the device was manufactured.

In an updated communication late 2016, the FDA provided new information about these types of infections after published European studies suggested “a direct link between the M. chimaera that infected European patients during open-chest cardiac surgery, and the M. chimaera isolated from the 3T heater-cooler model utilized during these patients’ surgeries.”

Greg Jones Law is taking cases nationwide for people who have suffered infection or other injuries after surgery with the Sorin T3 heating-cooling system. If you or a loved one suffered from infection after open heart surgery, contact us today for a free case evaluation.

The problem with Sorin T3

Although the water in the circuits does not come into direct contact with the patient, “there is the potential for contaminated water to enter other parts of the device or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient,” said the FDA in its safety communication to health care providers, hospitals and patients who had undergone cardiothoracic surgery.

The European studies included environmental samples taken from devices at the manufactures production and servicing facility in Germany. Testing conducted in August 2014 found M. chimaera contamination on the production line and water supply at the T3 facility. After the study, the manufacturer added cleaning and disinfection procedures to the production line. Yet, the FDA said it became aware of some 3T devices manufactured after September 2014 that tested positive to the same bacteria.

Potentially deadly M. chimaera

M. chimaera is the abbreviation for a type of nontuberculous mycobacterium (NTM) that can cause severe illness and even death. People exposed to these dangerous bacteria begin to feel symptoms within days.

Unfortunately, symptoms can also lay latent, sometimes for years after initial exposure, in some cases up to 3-5 years afterwards. Without treatment, it could result in death.

Many who were infected also had to undergo an additional surgery or a prolonged treatment (sometimes up to a year) of additional antibiotics.

There may be an increased risk of infection if you received a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product/material or had a heart transplant, according to the FDA.

If you have undergone cardiopulmonary bypass, be aware of these possible signs and symptoms of NTM infection:

• fatigue
• fever
• pain
• redness, heat, or pus at the surgical site
• muscle pain
• joint pain
• night sweats
• weight loss
• abdominal pain
• nausea
• vomiting

Did the manufacturer know?

The manufacture of the Sorin T3 heating-cooling system did know of a link to the bacteria before the FDA issued the safety communication. Ultimately, the Sorin Group admitted that the M. chimaera had been detected in their productions lines and water sources.

As a result, the plaintiffs in these lawsuits also claim that the manufacturer neglected to report contamination of their production facilities. By doing so, they additional failed to ensure the safety of their product.

The link to the bacteria was exposed to the public on June 1, 2016 by the FDA, making health officials and patients alike aware of the deadly consequences of having used a defective medical device.

If you suffered injuries after open heart surgery

Plaintiffs in these cases reported infections and infection-like symptoms, but were not always alert to the underlying danger.

Some suffered further complications after open-heart surgery involving a heating-cooling device. The consequences of Sorin’s dangerous product have been severe enough to include death in some cases.

If you experienced any of these consequences, you should contact an attorney as quickly as possible.

It’s important to have an experienced attorney in this type of litigation on your side. Greg Jones Law has successfully sued major medical device manufacturers for failing to warn of the dangers of their products. We have the means to represent clients throughout the United States.

To get a free case consultation against the makers of the Sorin T3 heating-cooling device, call 855-JONES-LAW (855-566-3752) or contact us online. No hassle and no obligation.

Put an experienced medical device lawyer on your side, contact Greg Jones Law today.

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