The Stockert 3T Heater-Cooler is a device used throughout the county in cardiac surgeries keeping patients’ body temperature steady while under anesthesia.

However, the FDA and CDC have both issued public warnings of heater-cooler infection risk, warning that patients could potentially develop a very rare and possibly fatal bacterial infection after surgery.

A recent investigation by KSDK of St. Louis analyzed recent injury reports allegedly linked to the Stockert 3T Heater-Cooler and the device’s risk to heater-cooler infection risk. The investigation looked into the reported bacterial infections and whether or not hospitals are notifying patients of the heater-cooler infection risk.

The Stockert 3T Heater-Cooler System is used in over 60% of open heart surgeries in the United States and is considered a very important tool for cardiac procedures. Manufactured by LivaNova PLC, this device is meant to keep internal organs and blood at a sufficient temperature during bypass procedures.

While this product has helped thousands of patients throughout the country, reports of deadly bacterial infections have caused panic in the medical community.

Cardiac patient Rene Knott’s life was saved by his cardiac procedure. However a month after his pulomonary thromboendarterectomy in July 2016, Knott was warned of the heater-cooler infection risk from his hospital. However the news investigation indicates that many other patients may not have been informed because neither the FDA or CDC require healthcare facilities to do so.

“It’s very expensive to go back and find those patients, find their addresses, contact them,” said Director of Consumers Union’s Safe Patient Project Lisa McGiffert.

Consumer advocates state because neither the FDA nor CDC require hospitals to cease use, remove this equipment, or warn patients, individual states should take a stronger initiative role in regulating these heater-cooler infection risk.

Overview of Stockert Cardiac Heater-Cooler Complications

The Stockert Cardiac Heater-Cooler is a surgical device using temperature controlled water to regulate patients’ body temperature. While this device is not supposed to interfere with the sterile surgical environment, reports of deadly bacterial infections have left many questioning whether or not to use the device.

It may take years for patients to develop symptoms of the bacterial infection, known as non-tuberculosis myobacteria. The FDA states that “there is potential for contaminated water to enter other parts of the device and aerolize,” which means the dangerous bacteria cane become airborne and transmitted “through the device’s exhaust vent into the environment and onto the patient.”

The CDC and FDA issued warnings to hospitals throughout the country, of the heater-cooler infection risk. One representative stated that approximately “50% of patients identified from this infection have died,” with experts warning that the aerosolized water may be blowing into the patient’s open chest.

The FDA stated between January 2010 and January 2016, at least 79 patients became infected with the bacteria and at least 12 patient deaths have been reported in 10 different states. Even with the heater-cooler infection risk so prevalent, advocates complain of the lack of communication with patients.

Even though many hospitals are trying to correct this miscommunication, consumer advocates advise patients to be vigilant against against non-tuberculosis myobacterial infection symptoms including night sweats, muscle aches, persistent fever, weight loss, fatigue and shortness of breath.