Stockert 3T Heater-Cooler System Attorneys
FDA Recall, Warning or Action: The FDA issued a warning about the Sorin Stockert 3T heater-cooler system, which has been linked to a dangerous infectious microorganism.
It’s an unfortunate fact that the medical procedures and devices that health may depend upon sometimes pose a danger to patients’ well-being. At Harrell & Harrell, P.A., we regularly review medical case rulings and warnings that are issued by federal and state agencies about drug companies’ and medical equipment manufacturers’ failure to fully protect or inform patients about their products.
SIDE EFFECTS OF STOCKERT 3T HEATER-COOLER SYSTEMS USE
LivaNova manufactures the Sorin Stockert 3T heater-cooler, which is used during some cardiac surgeries. The system uses both warm and cool water to regulate patients’ blood and organ temperatures while cardiac activity is temporarily stopped when invasive surgeries are being performed on the lungs, heart, esophagus, or other organs in the chest.
Research revealed that a dangerous bacteria—Mycobacterium chimaera (M. chimera)—can grow in and contaminate water kept in tanks in these systems as well as during the manufacturing process. The microorganism poses a danger when vapors from the contaminated water is spread in sterile operating suites by the system’s exhaust fan. The vapor can enter a patient’s open heart cavity, posing a danger of deadly infections to those with compromised immune systems.
The Centers for Disease Control (CDC) has estimated that more than 500,000 patients could be at risk of infection, since nearly 60 percent of the 250,000 heart bypass surgeries done each year use the Stockert 3T system. According to the CDC, infections resulting from this are difficult to treat, even with the most potent antibiotics.
It may take years for the M. chimaera infection to develop in patients, with most people showing symptoms within four years.
If you or a loved one have concerns regarding heart surgery that involved the use of the Stockert 3T heater-cooler, it’s important to speak with legal counsel. Call us at 904-251-1111 or 1-800-251-1111, or complete the form at the top of the page to get in touch with one of our expert attorneys.