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Contaminated Devices Putting Open-Heart Surgery Patients at Risk

Robins Kaplan LLP is currently investigating claims regarding Sorin Stockert 3T Heater-Cooler Devices.  The Sorin Stockert 3T heater-cooler system is designed to raise or lower the temperature of a patient during cardiopulmonary bypass procedures.1

The Stockert 3T heater-cooler devices might have been contaminated during manufacturing, which could put patients at risk for life-threatening infections.2  The U.S. Food and Drug Administration and the Center for Disease Control are warning that Mycobacterium chimaera (M. chimaera) infections are associated with the use of the 3T in U.S. patients who have undergone cardiothoracic surgeries.3 M. chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower and may cause serious illness or death.4

On June 1, 2016, the FDA issued a Safety Communication specific to M. chimaera infections associated with the use of the 3T.5 Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.6 The CDC is advising patients who have had open heart surgery to seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.7

Potentially contaminated heater-cooler devices were used at the Mayo Clinic in Rochester, Minnesota.8 The Clinic notified 17,000 patients who had heart surgery since the Clinic started using the device that they may have been infected.9  The machines have been found to be a problem at 16 other hospitals across the country.10

We are interested in speaking with individuals who have been harmed by a bacterial infection after undergoing cardiothoracic surgery requiring cardiopulmonary bypass in which they were exposed to a Sorin Stockert 3T heater-cooler system. 

Robins Kaplan LLP is experienced with products-liability litigation and is dedicated to giving our clients the highest quality representation.  We welcome calls from referring attorneys or potential clients.  Contact us at 1-800-553-9910 or at 1-612-349-8500 or by clicking here.


1 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm
2 https://www.cdc.gov/hai/outbreaks/heater-cooler.html
3 http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/UCM520191.htm; https://www.cdc.gov/hai/outbreaks/heater-cooler.html
4 Id.
5 Id.
6 Id
7 https://www.cdc.gov/hai/outbreaks/heater-cooler.html
8 http://www.kttc.com/story/33684252/medical-machine-poses-risks-during-open-heart-surgery
9 Id.
10Id.