FDA Adds New Warning To Remove Contaminated 3T Heater-Cooler Devices Used In Heart Surgeries

Print

3T Heater-Cooler Lawsuits Notes FDA Advisory For Health Care Facilities To Immediately Remove Stӧckert 3T Heater-Cooler After M. chimaera bacteria Was Found

3T heater-cooler lawsuits Heater-Cooler-Lawsuit -3T-heater-cooler-infection-lawsuitThe attorneys at Wright & Schulte LLC who have been investigating 3T Heater-Cooler Lawsuits, will look closely at The U.S. Food and Drug Administration (FDA) recent Device warning on heater-Cooler infections. The FDA has advised health care facilities to immediately remove any Stӧckert 3T Heater-Cooler devices and accessories that have tested positive for Mycobacterium chimaera (M. chimaera) bacteria. The FDA urged facilities not to use heater-cooler devices made prior to September 2014 for open-chest cardiac surgery until the manufacturer, LivaNova PLC (formerly Sorin Group Deutschland GmbH) resolves contamination issues with the device. The risk of infection from contaminated heater-coolers used during heart surgeries are spurring 3T heater-Cooler lawsuits. The complaints are filed on behalf of patients who allege they were exposed to nontuberculous mycobacterium (NTM), specifically M. chimaera bacteria, during a surgery that used a Stӧckert 3T Heater-Cooler System.

The 3T Heater-Cooler System is used to warm or cool a patient during surgery. The FDA first warned in June that the heater-cooler’s water tanks can become contaminated and enter other parts of the device and transmit airborne bacteria through the machine’s exhaust vent into the environment and to the patient. In its October 13th safety communication, the FDA recommended, among other things, that health care providers and doctors direct and channel the heater-cooler exhaust away from patients. Since the FDA warnings, 3T Heater-Cooler lawsuits have been filed
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm]

“The FDA’s most recent safety communication shows that there are still problems with contaminated heater-cooler devices allegedly causing patients to develop life-threatening infections,” 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.

Stӧckert 3T Heater-Cooler devices are used during cardiothoracic (heart, lung, chest) surgeries to keep patients warm or cool. The devices have water tanks that provide temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits. Patients do not come into direct contact with water in the circuit, the FDA says. In December 2015, the FDA sent LivaNova a warning letter after inspecting the company’s facilities in Germany and Colorado. The federal agency found violations at LivaNova’s Munich, Germany facility that included a failure to adequately validate and verify procedures for cleaning and disinfecting heater-cooler devices. LivaNova told the FDA that it is working to resolve the violations.
[fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm479684.htm, FDA, December 29, 2015]
[globenewswire.com/news-release/2016/01/05/799648/0/en/LivaNova-PLC-Provides-Update-on-FDA-Warning-Letter.html, LivaNova]

Court documents show that LivaNova is defending itself against heater-cooler lawsuits filed on behalf of patients who developed NTM infections allegedly after undergoing cardiothoracic surgeries. In one instance, two Pennsylvania men who jointly filed a lawsuit are seeking class-action status on behalf of 3,600 patients who had heart procedures at Wellspan York Hospital or Penn State Milton S. Hershey Medical Center, both in Pennsylvania. The lawsuit said both plaintiffs underwent bypass surgeries in March 2015 at York Hospital and were exposed to the NFM bacteria. (Soren Heater-Cooler Lawsuit Case No. 1:16-cv-00260, U.S. District Court, Middle District of Pennsylvania) York Hospital identified 11 patients with NTM infection, six of whom have died. Similarly, Hershey Medical Center has confirmed three NTM-infected patients, two of whom have died.
[wellspan.org/media/1243364/WYH-OpenHeart-FAQ-Providers.pdf, Wellspan York Hospital, August 26, 2016]
[pennstatehealthnews.org/2015/11/medical-center-notifies-open-heart-surgery-patients-of-possible-infection-risk/]

About Wright & Schulte LLC And Filing A 3T 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. 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

This entry was posted in Wright & Schulte Lawsuit News. Bookmark the permalink.