Lawsuits Filed Against the Makers of the "Stockert Device"
Lawsuits have been filed against the makers of the Stockert/Sorin 3T Heater-Cooler system (the “Stockert Device”) by patients who developed life threatening infections after the device was used during their heart bypass surgery.
Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (“CDC”) have issued safety warnings concerning these infections.
The Stockert Device helps keep organs and blood at their proper temperature during bypass surgeries. However, the FDA warns that there is potential for contaminated water to enter other parts of the device causing bacteria to be transmitted in the air and into the operating room environment and the patient.
Approximately 250,000 heart bypass procedures are performed in the United States each year using a heater-cooler device. The Stockert Device is used on about 60% of these. There are approximately 2000 Stockert Devices in U.S. hospitals. The FDA and the CDC have stated that the infected devices, manufactured in Germany, may have been used in the U.S. as early as 2006 but report that no infections have been linked to Stockert Devices manufactured after September of 2014.
Even with this widespread use of the Stockert Device, the chances of actually developing the M. chimera virus is rare, however, the FDA explains that the infection may take many months and even years to develop. Accordingly, early testing for the virus is advised. Left unchecked, the infection can spread and become more difficult to treat. Some of the early symptoms of the virus include:
- Night Sweats
- Muscle Aches
- Weight Loss
- Unexplained Fever
If you are not certain the Stockert Device was used in your operation, you should immediately consult with your surgeon.