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Contaminated 3T Heater-Cooler Systems commonly used during heart surgery are believed to be responsible for infections among at least a dozen children at Children’s Hospital in New Orleans.
Last week, the hospital issued a statement announcing that at least 12 children who underwent heart surgery between May and July 2017 have tested positive for Mycobacterium abscessus surgical site infections.
While the hospital did not mention the 3T Heater-Cooler system by name, other media outlets have confirmed that a medical device linked to similar heart surgery infections in recent years was involved in the treatment at the Children’s hospital.
“Because a common element in the affected children was open-heart surgery requiring the use of cardiopulmonary bypass, our investigation focused on the environment and equipment used in the cardiac operating room,” the hospital’s statement notes. “We believe a piece of equipment used to regulate the temperature of patients while on bypass is the most likely source of this infection, and all suspected equipment has been removed from service and replaced.”
The hospital has sent out at least 55 letters to patients who may have been exposed to the contaminated 3T Heater Cooler system.
A number of open heart surgery infection lawsuits filed in courts nationwide against the makers of the 3T Heater-Cooler, alleging that the contamination risk was known and inadequate steps were taken to warn the medical community, the FDA and heart surgery patients.
Similar hospital warning letters to heart surgery patients have been sent by other facilities nationwide, after it was discovered that problems with the 3T Heater-Cooler System were causing the heart surgery infections.
The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.
In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.
Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.
The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.
Children’s Hospital in New Orleans has announced it will pay all clinical costs for treating and evaluating infections linked to the use of the 3T Heater Cooler system in its facility.