Heart Surgery Infections linked to 3T Heater-Cooler Systems
The FDA released an updated safety communication warning that cardiothoracic surgery with Stockert 3T heater-cooler devices had been linked with slow growing Mycobacterium chimaera infections. The CDC issued an alert on Oct. 13, 2016, advising U.S. hospitals that used the device to alert patients to the potential for NTM, a rare form of bacteria called non-tuberculous mycobacterium.
Manufacturer Sorin Group Deutschland GmbH and the Sorin Group USA, Inc. knew about the link for several years and tracking the source of NTM began more than a decade ago in Western Europe hospitals. In 2015 a hospital in Eastern Pennsylvania identified the infections among patients who had undergone open-heart surgery there. Also in Pennsylvania, a lawsuit was filed in July 2016 against the Stockert 3T manufacturer (the hospital in question is not mentioned). According to the Pennsylvania Record, plaintiff Richard Whipkey underwent an aortic valve replacement in May 2015 and one year later he developed “unexplained symptoms” that lab tests determined was the deadly infection.
Richard and Elizabeth Whipkey filed suit in Pennsylvia after he developed infection months after undergoing aortic valve replacement. The case is U.S. District Court for the Middle District of Pennsylvania case number 1:17-cv-01233-JEJ and will be tried against the manufacturers of the Stockert 3T heater-cooler device.
Parents have filed complaints against Children’s Hospital of New Orleans after their children developed mycobacterium abscessus bacterial infections after undergoing heart sPart of the CDC report warned the following: “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year.”
Children’s Hospital Chief Medical Officer Dr. John Heaton said the hospital had two ‘Stockert 3Ts’ when they received the CDC report. And one of the devices was involved in the FDA advisory. The hospital has assumed all cost of treatment for families affected by this infection. An attorney for the parents of Children’s Hospital patients said that “Our goal and charge is to figure out what Children’s Hospital knew, when and what they should have done.” The parents may also file a product liability suit against the manufacturer.