Several Indiana hospitals are warning thousands of open heart surgery patients about a risk of infection linked to heater-cooler devices used during the procedure.
Free Confidential Lawsuit Evaluation: If you suffered an infection or other injury after undergoing surgery in which a heater-cooler device was used, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
What’s the Problem?
January 3, 2016 – The Centers for Disease Control and Prevention (CDC) issued a warning in October that some LivaNova Stöckert 3T heater-coolers may have been contaminated during manufacturing, putting patients at risk of life-threatening nontuberculous mycobacterium (NTM) infections.
The devices use water tanks to provide temperature-controlled water to keep patients warm or cool during surgery. Although the water does not come into contact with patients, FDA warned that contaminated water could enter other parts of the heater-cooler, which could then be sprayed through its exhaust vent.
Franciscan Health sent letters to 800 patients at its hospitals in Indianapolis, Crown Point and Lafayette who were treated with Stöckert 3T heater-coolers. Community Health Network notified about 600 patients of Community Heart and Vascular Hospital, and the Richard L. Roudebush VA Medical Center contacted 430 patients.
About 150,000 heart bypasses in the U.S. each year involve use of heater-cooler systems, according to the CDC. The agency estimated that in hospitals that used the devices and where at least one NTM infection has been reported, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.
Although the infections can be severe and some patients have died (at least 12 patients have died from complications of NTM infections), CDC said it is unclear whether the infection was a direct cause of death. Patients who had valves or prosthetic implants are at an increased risk of infection, according to the agency.
In a statement, Community Health Network said it began using one Stöckert 3T heater-cooler in 2012 at Community Heart and Vascular Hospital, but decommissioned the system three years later after it learned of the potential for contamination. The device was subsequently tested by an independent laboratory and showed no signs of contamination.
Do I have a Heater-Cooler Lawsuit?
The Product Liability & Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently accepting new infection cases in all 50 states.
Free Case Evaluation: Again, if you developed an infection or other injury after undergoing surgery with a heater-cooler device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.