The source of the contamination can occur in 2 places:
- The manufacturing plant
- The hospital
The two potential contamination issues increase the risk of infection in patients.
The bacterium, commonly found in soil or water, is typically not harmful, but is slow-growing and can cause infections in those undergoing surgery or suffering from a suppressed immune system.
Becoming available to the market in 2006, the device has been used in over 250,000 heart bypass surgeries throughout the United States.
- 60% of those surgeries used the Stockert 3T Heater-Cooler System.
The FDA has said that similar devices may also have the same design flaw as the Stockert 3T Heater-Cooler system that causes bacterium infections.
The flaw relates to contamination during the manufacturing period.
Since 2010, about 79 cases of infection, including 12 deaths, caused by the use of the Stockert 3T Heater-Cooler System have been reported to the U.S. Food & Drug Administration.
As a result, Stockert 3T heater-cooler device lawsuits are being filed across the country on behalf of those who have suffered injuries resulting from contamination.