FDA: Sorin Heater-Cooler Device Associated With Bacterial Infections, Heater-Cooler Lawsuits

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Wright & Schulte LLC Is Investigating Heater-Cooler Lawsuits Alleging Patients Developed Infection Due to The Contaminated Medical Device.

Heater-Cooler Lawsuit  3T-heater-cooler-infection-lawsuitThe U.S. Food and Drug Administration (FDA) recently warned that the Stӧckert 3T heater-cooler device may cause a certain type of bacterial infection in patients undergoing heart procedures. The federal agency received reports that patients were exposed to the non-tuberculosis mycobacteria (NTM), specifically Mycobacterium chimaera (M. chimaera) bacteria, when a contaminated 3T heater-cooler device was used during surgery. Patients who have been exposed to NTM infections are filing heater-cooler lawsuits against LivaNova PLC (formerly Sorin Group Deutschland GmbH), which makes the Stӧckert 3T heater-cooler device, and hospitals where the potential bacterial infection occurred.

heater-cooler lawsuits have been filed against LivNova PLC

Court documents indicate 3T heater-cooler lawsuits have been filed against LivNova PLC, and The Sorin Group USA Inc. on behalf of patients who developed NTM infections allegedly from the company’s contaminated medical device. A heater-cooler lawsuit complaint was recently filed on behalf of a South Carolina man who underwent an aortic valve replacement and bypass surgery in May 2014. A Sorin 3T Heater-Cooler System was used, exposing him to NTM, the complaint said.
(Heater-Cooler Lawsuit Case No. 8:16-cv-02688, U.S. District Court, District of South Carolina)

“We are investigating NTM infection cases related to the 3T heater-cooler device because patients have been seriously and fatally injured and deserve justice for the pain and suffering they have endured,” says Wright & Schulte LLC.

The 3T Heater-Cooler Lawsuit Attorneys at Wright & Schulte LLC are currently offering free 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.

FDA issues safety announcement warning patients about increased risk of infection due to 3T heater cooler

The FDA issued a safety announcement in June warning that patients who have received a heart valve, graft, a left ventricular assist device or any other prosthetic product, or heart transplant are at an increased risk of infection when the 3T heater cooler is used. According to the federal agency, efforts are underway in the United States to determine if the infections in U.S. patients and bacterial samples taken from the 3T heater-cooler are linked with M. chimaera isolates from European patients who were infected and the M. chimaera previously identified at the LivaNova’s production and servicing facility in Germany. In December 2015, the FDA sent LivaNova a warning letter outlining violations found at its Germany facility, that included failure to adequately validate and verify procedures for cleaning and disinfecting its heater-cooler devices.
[fda.gov/medicaldevices/safety/alertsandnotices/ucm466963.htm, FDA, October 15, 2015]
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm504213.htm, FDA, June 1, 2016]

Iowa Hospitals and Clinics and WellSpan York Hospital in Pennsylvania send warning letters to patients that they may have been exposed to NTM infections during surgery

Heater-cooler devices are used during cardiothoracic and other surgeries to keep patients warm or cool. The devices include water tanks that provide temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits. Although patients do not come into direct contact with water in the circuits, contaminated water can potentially enter other parts of the device or transmit airborne bacteria through the device’s exhaust vent into the environment and to the patient. In February, the University of Iowa Hospitals and Clinics sent letters to 1,700 patients warning them that they may have been exposed to NTM during heart, lung and liver surgeries. Similarly, WellSpan York Hospital in York, Pennsylvania, confirmed 11 patients with NTM infection, six of whom have died.
[ press-citizen.com/story/news/local/2016/02/05/university-of-iowa-hospitals-surgery-patients-infection-risk/79813714/, Iowa City Press-Citizen, February 5, 2016]
[wellspan.org/media/1243364/WYH-OpenHeart-FAQ-Providers.pdf, Wellspan York Hospital, August 26, 2016]

About Wright & Schulte LLC And Filing A Heater-Cooler Lawsuit

Wright & Schulte LLC, an experienced personal injury 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 that will guarantee the aggressive and personal representation you deserve, please do not hesitate to contact Wright & Schulte LLC today. The 3T Heater-Cooler Lawsuit Attorneys at Wright & Schulte LLC are currently offering free 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.

Contact:
Wright & Schulte LLC
865 S. Dixie Dr.
Vandalia, Ohio 45377
1-800-399-0795
www.yourlegalhelp.com

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