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 Stockert 3T Heater-Cooler System is made by LivaNova PLC (formerly Sorin Group Deutschland) and is sometimes labeled the “Sorin 3T Heater-Cooler System.” It is considered a very important device 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.
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The FDA and CDC are reporting that the Stockert 3T heater-cooler devices were allegedly contaminated with a 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 issue was reportedly resolved in July 2015 when the facility was tested again, and the FDA says that no infections allegedly caused by heater-cooler devices have been linked to 3T devices manufactured after September 2014. The FDA issued its first safety communication in October 2015 when it reported that the federal agency had received 32 Medical Device Reports (MDR) concerning patients that had developed infections allegedly caused by heater-cooler devices. At that time, the FDA did not name any specific devices at issue, but said that it planned to “monitor the situation.”
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. According to the CDC, there has been a total of 28 confirmed infections. According to the FDA, at least 12 patients may have died as a result of the infection. Because of the late-onset of the infection, the CDC is encouraging heart surgery patients who are experiencing the following symptoms to seek medical attention:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained Fever
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A 3T Heater-Cooler device class action lawsuit was filed in recently by open-heart surgery patients alleging that LivaNova knew or should have known about the defects linked to the 3T Heater-Cooler System that left patients unwittingly “exposed to a potentially fatal bacteria” during surgery. Several 3T Heater-Cooler infection individual lawsuits have also been filed. 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.