Heater-cooler units are medical devices used during open-heart surgery to help regulate blood and body temperature. One of the most popular heater-cooler devices is the Sorin Stöckert 3T system, made by Sorin Group Deutschland, a subsidiary of LivaNova, and sold in the United States by Sorin Group USA. The Sorin 3T device is used in 60 percent of hospitals that perform heart surgery.
Sorin 3T devices use independent water tanks and a compression-based cooling system to keep patients at the desired temperature during surgery. However, bacterial contamination at Sorin’s Germany-based factories, along with poor design, has led to a significantly increased risk of developing deadly postoperative infections from nontuberculous mycobacteria (NTM).
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What Consumers Should Know About Sorin 3T Heater-Coolers
Sorin 3T units are most commonly used during cardiac bypass surgery or other open-chest operations. If you or a loved one is going to have one of these procedures, you may want to ask a member of the medical team about the equipment that will be used.
NTM Infections Caused by Sorin 3T Units
The Centers for Disease Control and Prevention (CDC) warn that between 1 in 100 and 1 in 1,000 patients could be at risk of developing a deadly infection after open-heart surgery due to a 3T heater-cooler. With nearly a quarter million cardiothoracic surgeries occurring each year in the U.S., that’s potentially thousands of people who could become sick or even die from a systemic NTM infection. Some of the side effects people experienced included sudden weight loss, night sweats, and chronic coughing.
As early as 2010, the U.S. Food and Drug Administration (FDA) received reports about infections caused by Sorin 3T devices. After a visit to the Sorin factory in Germany in 2011, the regulatory agency found that the company’s cleaning instructions were insufficient for preventing bacterial contamination: Bacterial growth was found as soon as a day and a half after factory cleaning recommendations, which the company claimed should have keep the 3T units free of pathogens for at least two weeks.
The primary source of concern is a form of NTM bacteria known as Mycobacterium chimaera. Although this type of bacteria is commonly found in nature, when introduced into the body through an incision, it can cause severe, and possibly even fatal, M. chimaera infections (sometimes referred to as Mycobacterium avium complex infection).
Hospitals Issue Sorin Stöckert 3T Warnings to Patients
After the CDC issued a press release announcing that open-heart surgery patients were at risk of developing deadly infections, hospitals began to send notices to patients who might have been exposed. Prominent hospitals in Pennsylvania, South Carolina, Missouri, Iowa, and other states sent these infection notices to thousands of patients who had received a bypass operation in the preceding months.
Because Sorin 3T devices are used in a large number of hospitals all over the country, it’s possible many more patients were affected by bacterial infections. If you or a loved one received heart surgery and did not get a notice from your hospital, you may want to check with your doctor to find out if you could have been affected.
Sorin 3T Recall
In December 2016, Sorin issued a recall on its 3T heater-cooler devices. Unlike other medical device recalls, the recall did not require a return of the equipment or replacement of a defective part. Rather, the recall simply updated cleaning and disinfecting instructions for Stöcker 3T Heater-Cooler systems. The FDA also issued a safety communication for hospitals and the public with information about the recall.
Some people have argued that the Sorin recall did not go far enough. As noted above, the FDA found that the company’s disinfecting instructions were not adequate to keep bacteria from growing on the devices. The FDA has identified other potential problems with the design of 3T systems, including a contaminated water supply and exhaust vents that could distribute bacteria around the operating room.
Sorin 3T Lawsuits
Because of the problems associated with Stöckert 3T Heater-Cooler devices, a number of cardiothoracic surgery patients (or their survivors) have filed lawsuits against Sorin Group and its parent, LivaNova PLC. Several dozen of these have been consolidated under a federal multidistrict litigation (MDL 2816) in Pennsylvania, and more are expected to be submitted.
If you or a loved one required treatment for an NTM infection or another bacterial infection after having an open-chest operation, you should contact a lawyer right away for a free case review.
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