FDA Warns Risk Of Mycobacteria Infection Or Bacterial infections During Heart Surgery From Contaminated Stӧckert 3T Heater-Cooler Surgical Equipment.
As Heater cooler infection lawsuits are filed in the United States, attorneys are leaning officials in Australia are also warning patients about the potential risk of Mycobacterium chimaera (M.chimaera) infection. The warning comes shortly after the U.S. Food and Drug Administration (FDA) issued a warning that surgical heater-cooler devices could potentially cause bacterial infections from the contaminated devices used during cardiac surgery. While Australian officials did not name the heater-cooler’s manufacturer, U.S. patients who were exposed during surgery to non-tuberculosis mycobacteria, specifically M. chimaera, have filed lawsuits against LivaNova PLC, which manufactures the Stӧckert 3T heater-cooler device.
NSW Health officials in Australia issued the warning after discovering a patient was possibly infected in 2015 with M.chimaera following cardiac surgery in which a heater-cooler device was used. As a result, health officials replaced surgical heater-cooler devices in four hospitals in Sydney, according to a report in The Sydney Morning Herald. NSW also advised patients who recently had open heart surgery at the hospitals in the last five years to consult their doctors.
“It is important for patients to maintain contact with their doctors since the FDA says that patients exposed to M. chimaera may not develop symptoms or signs for months to years after their initial exposure,” says Wright & Schulte LLC, a nationwide law firm which represents plaintiffs who have been harmed by medical devices.
The Heater-Cooler Lawsuit Attorneys at Wright & Schulte LLC are currently offering free Sorin 3T Heater-Cooler Lawsuit legal evaluations to those who believe they or their loved ones may have sustained injuries from a contaminated heater-cooler device. To learn more, please contact the 3T Heater-Cooler Lawsuit Attorneys at Wright & Schulte today by calling 1-800-399-0795 or through yourlegalhelp.com.
Bacterial infections during open heart surgery due to contaminated heater-cooler units have occurred for years. However, the link was first made in Switzerland in 2012 after M. chimaera infections were diagnosed in two heart surgery patients. Researchers at the University of Zurich launched an investigation and found six patients who had complications due to M. chimaera that manifested between 1.5 and 3.6 years after surgery. In March, the FDA said it has received 32 reports worldwide of patient infections linked with heater-cooler devices between January 2010 and August 2015. Of the total, eight reports occurred in U.S. health care facilities.
[ncbi.nlm.nih.gov/pubmed/25761866, Clinical Infectious Diseases Advance Access]
The 3T Heater-Cooler device, manufactured by LivaNova PLC (formerly known as Sorin Group Deutschland GmbH), keeps patients warm or cool during cardiothoracic and other surgeries. Patients do not come into direct contact with water in the heater-cooler unit, but contaminated water can potentially enter other parts of the unit or transmit airborne bacteria through the device’s exhaust vent into the environment and to the patient, according to the FDA.
Court documents indicate that the Sorin Group is named as a defendant in heater-cooler lawsuits. PennLive reported a lawsuit was recently filed on behalf of a 62-year-old Pennsylvania man who died in November 2015 of a rare heart infection that was linked to Sorin’s heater-cooler device used during the man’s heart surgery. WellSpan Health and WellSpan’s York Hospital were also named as defendants.
[pennlive.com/news/2016/06/david_inners_hanover_infection.html, PennLive, June 27, 2016]
About Wright & Schulte LLC And Filing A Heater-Cooler Lawsuit
Wright & Schulte LLC, an experienced personal injury firm, continually speaks with men and women from around the country injured by medical devices such as the Sorin 3T Heater-Cooler. The firm is dedicated to the belief that America’s legal system should work for the people. Every day, the attorneys of Wright & Schulte LLC stand up for the rights of people who have been injured or wronged and fight tirelessly to ensure that even the world’s most powerful corporations take responsibility for their actions. If you’re looking for a law firm who is passionate about t’s clients and guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. Free Heater-Cooler lawsuit case evaluations are available through yourlegalhelp.com or by calling 1-800-399-0795.
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