A dozen children who were treated in June and July at New Orleans Children’s Hospital have developed an open heart surgery infection.

The Stockert 3T Heater-Cooler System by LivaNova PLC was used during each of the pediatric patient’s surgeries. The machine uses water to maintain the temperature of blood and organs during open heart surgery. The water does not come into contact with the body, but the device creates a mist that can disseminate harmful substances in the air. These contaminated particles can settle into the open chest cavity where they can fester for months or years.

The device is also known as the Sorin 3T Heater-Cooler System, which was its name under LivaNova’s predecessor, Sorin Group Deutschland.

In October 2016, the FDA and the Centers for Disease Control issued warnings regarding the use of Stockert 3T heater-coolers because tests showed many of the devices were tainted with a potentially deadly Myobacterium chimaera. Manufactured in Germany, the cardiac heater-cooler unit has been linked to patient deaths related to infections since January 2014.

Tests have concluded that the strain of Myobacterium chimaera found in the machines is the same as that found in environmental samples from the production and servicing facility in Germany. This bacteria linked to the open heart surgery infection can be found naturally in soil and water.

Researchers produced a study at the 44^th Annual Conference of Association for Professionals in Infection Control and Epidemiology in June of this year that indicated 37 percent of Stockert 3T heater coolers tested from June 2015 to December 2016 contained Myobacterium chimaera contamination. Further tests revealed evidence of other non-tuberculous mycobacteria, Legionella, and fungi.

The FDA recommends using new accessories, tubing and connectors with the heater-cooler machines, and directing the exhaust fan away from the patient. At least one hospital has gone a step further by creating an area that allows the placing of the exhaust fan part of the device in a room separate from the patient.

Disinfecting the closed circuit machines has been problematic. Hospital staff have complained that inadequate cleaning directions were provided with initial shipments of the Stockert 3T heater coolers.

The FDA also warns patients there is an increased risk of infection for patients who receive a heart valve, graft, left ventricular assist device (LVAD), or any other prosthetic product, or have had a heart transplant.

Lawsuits Filed over Open Heart Surgery Infection

Several adults in the U.S. and Canada have filed lawsuits because they developed open heart surgery infection. Some of those lawsuits are seeking class action status.

The discovery of children developing open heart surgery infection at the New Orleans Children’s Hospital leaves the hospital and the heater-cooler manufacturer both targets for lawsuits because the risks of infection and the need for proper disinfection were known before the surgeries were performed.

If you or someone you know developed an open heart surgery infection after a heater-cooler device was used, you could be eligible for compensation through legal representation.