Stockert 3T Heater-Cooler FDA Warning
Stockert 3T Heater-Cooler safety warnings have been issued by both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) alleging that the devices are linked to serious and potentially deadly infections. The makers of the Stockert 3T Heater-Cooler System (sometimes called the Sorin 3T Heater-Cooler System) are facing lawsuits filed by patients alleging that they developed life-threatening infections after the heater-cooler device was used during their heart surgeries.This device is used during heart surgeries because it works to help keep organs and blood at the proper temperature during bypass procedures.
Heater-cooler devices include water tanks with temperature controlled water that do not contact patients directly, but the FDA says that “there is potential for contaminated water to enter other parts of the device and aerosolize,” which means the bacteria can be transmitted in the air “through the device’s exhaust vent into the environment and to the patient.”Such devices are used by 250,000 open-heart patients during bypass surgeries every year. About 60 percent of those devices that are currently in use at hospitals around the country have been linked to potentially deadly infections. The devices may have been in the United States since 2006, the FDA said.
The FDA and CDC are reporting that the Stockert 3T heater-cooler devices were allegedly contaminated with bacteria called Mycobacterium chimaera when they were manufactured in Germany. M. chimaera contamination at the manufacturing facility was found during tests in September 2014.The FDA issued its first safety communication in October 2015 and in June 2016, the FDA reported that the development of M. chimaera infections were linked to the 3T heater-cooler devices made by LivaNova.The FDA issued its most 3T Heater-Cooler recent warning on Oct. 13, 2016 to provide health officials with additional recommendations on how to prevent the spread of infection.
While the FDA says that developing the M. chimaera infection is rare, it warns that the infection may take months to years to develop.
Bacteria infections linked to the 3T Heater-Cooler device have been reported in Iowa, Michigan and Pennsylvania beginning in 2011 to the present. Stockert 3T Heater-Cooler devices have been linked to spreading rare non-tuberculosis bacterial infections to patients such as Mycobacterium chimaera (M. chimaera), which can cause serious illness and even death. According to the CDC, there have been a total of 28 confirmed infections. According to the FDA, at least 12 patients may have died as a result of the infection.
Cardiac Heater-Cooler System Lawsuits
Open-heart surgery patients have begun filing 3T Heater-Cooler System lawsuits against LivaNova and Sorin Group.
If you or someone you know was hit with an infection following open-heart surgery after a 3T Heater-Cooler device was used during the procedure, you may be entitled to compensation.
Please contact Jamie Sheller Esq. 1 800 883 2299