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An Indiana man has filed a Sorin 3T heater cooler lawsuit against LivaNova PLC, alleging their cardiac heater cooler device had caused him to develop a potentially fatal infection.
The claimant filed the Sorin 3T heater cooler lawsuit soon after discovering that models of this device manufactured before September 2014 could have been contaminated by deadly mycobacterium chimaera (M. chimaera), but that the maker failed to notify the public in a timely manner.
Plaintiff Jason S. is filing the Sorin 3T heater cooler lawsuit alleging multiple claims of negligence and failure to warn, stating that he would not have agreed to have the cardiac heater cooler device used during his surgery if he had known about the risks According to the Sorin 3T heater cooler lawsuit, Jason underwent an aortic valve resection and ascending aortic aneurysm repair on Jan. 28, 2016.
Not long after this open heart surgery procedure, Jason reportedly began experiencing painful symptoms and a fainting spell that eventually forced him to return to the hospital on May 18, 2016. At this time, he underwent surgery to resolve blood clots and infection in the heart and lungs.
Jason says he eventually received notification that the Sorin 3T heater cooler used during his surgery may have been linked to potentially fatal bacterial infections in January 2017 from Indiana University Health. After receiving this notification, Jason had decided to file the Sorin 3T heater cooler lawsuit, stating the bacterial infection had caused permanent infractions in his life.
Due to the intensive medical treatment Jason had to undergo, he claims, he eventually lost his job and was unable to earn a sufficient wage while incurring medical bills.
Jason states he had no previous knowledge of the Sorin 3T heater cooler’s link to deadly bacterial infections, with him and his physician relying on the information provided about the device at the time from LivaNova PLC.
Overview of Cardiac Heater Cooler Infection Complications
The Sorin 3T heater cooler consists of two temperature controlled water tanks which do not directly make contact with the patient but still pose a significant risk.
According to the FDA, “there is potential for contaminated water to enter other parts of the device and aerosolize,” which means these bacteria can enter the air through the device’s exhaust vent. When the M. chimaera is released into the air, the bacterial cells could come into contact with the surgical site and cause infection.
The FDA issued its first safety warning regarding this correlation in October 2015, with the agency stating it had received 32 Medical Device Reports (MDR) from patients who allegedly developed heater cooler infections. While the FDA did not name the Sorin 3T heater cooler as the device in question at the time, the agency later confirmed the correlation in June 2016.
It is important to note that these bacterial infections can take months and sometimes years to develop, with patients needing to look out for the following symptoms:
- Night Sweats
- Muscle Aches
- Weight Loss
- Fatigue
- Sudden Fever
The devices linked with M. chimaera bacteria reportedly came from a manufacturing plant in Germany, when it was discovered there was bacteria contamination in September 2014.
This issue was reportedly resolved in July 2015, with the FDA stating there was no risk of infection from devices manufactured after September 2014. Even though cardiac heater cooler infections can be devastating to patients, plaintiffs claim LivaNova PLC allegedly failed to warn the public against the risk.
This Sorin 3T Heater Cooler Lawsuit is Case No. 1:18-cv-00245-JMS-TAB, in the U.S. District Court of Southern Indiana, Indianapolis Division.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The cardiac heater-cooler attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, cardiac heater-cooler lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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