Stockert 3T Heater-Cooler System under fire for Heart Infections. The manufacturers of the Stockert 3T Heater-Cooler System also known as the Sorin 3T Heater-Cooler System, are exposed to personal injury and product liability lawsuits. Injured patients claim that they developed severe bacterial infections after the heater-cooler device was used during heart surgeries.
What is the problem with Stockert 3T Heater-Cooler devices?
According to medical studies, the Stockert 3T Heater-Cooler devices have been linked to spreading bacterial infections to patients, which can cause severe illness.
FDA Warning: Stockert 3T Heater-Cooler
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 catastrophic 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 an important device during heart surgeries because it keeps vital organs and blood at the proper temperature during bypass procedures.
According to the FDA, “there is potential for contaminated water to enter other parts of the device and aerosolize, (the bacteria can be transmitted in the air) through the device’s exhaust vent into the environment and to the patient.”
Widespread use of the Stockert 3T Heater-Cooler
Such warming devices are used since 2006, by over 250,000 open-heart patients during bypass surgeries every year across the U.S. About 60 percent of those devices that are currently in use at hospitals around the U.S. have been linked to infections.
FDA and CDC Findings
The FDA and CDC are reporting that the Stockert 3T heater-cooler devices were allegedly contaminated with a bacteria called Mycobacterium chimaera (non-tuberculous bacteria) 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 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.
In June 2016, the FDA warned that 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 October 13, 2016 to provide doctors and hospitals with additional recommendations on how to prevent the spread of infection.
According to the FDA, developing the M. chimaera infection is rare, it warns that the infection may take months to years to develop.
3T Heater-Cooler device have been reported in Iowa, Michigan and Pennsylvania
Bacteria infections linked to the 3T Heater-Cooler device have been reported in Iowa, Michigan and Pennsylvania starting in 2011. The CDC reports that there has been a total of 28 confirmed infections. The FDA reports that at least 12 patients may have died as a result of the M. chimaera infection.
The CDC is recommending heart surgery patients who are experiencing the following symptoms to seek medical attention:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained Fever
Heart Surgery Infection Lawsuits
Open-heart surgery patients have begun filing 3T Heater-Cooler System lawsuits against LivaNova and Sorin Group.
A 3T Heater-Cooler device class action lawsuit was filed in February 2016 by open-heart surgery patients in Pennsylvania 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 succumbed to an infection following open-heart surgery after a 3T Heater-Cooler device was used during the procedure, please call us for further information.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.