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CDC Warns of Infection Risk from Heater Cooler Devices Used in Heart Surgery

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Santa Clara, CA; A warning has been issued by The Centers for Disease Control and Prevention (CDC) for healthcare providers and patients about the potential risk of infection from certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices used during open heart (open-chest) surgery.

Patients who have had open heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever. This advice follows new information indicating that some of the Stöckert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing. This could put patients at risk for life-threatening infections.

More than 250,000 heart bypass procedures that use heater-cooler devices are done every year in the U.S.. Heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections.

CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.

CDC also released today a Health Alert Network advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk.

CDC and the U.S. Food and Drug Administration initially published information and alerts about these potentially contaminated heater-cooler devices in 2015. CDC’s Morbidity and Mortality Weekly Report, just published, details recently completed laboratory tests by CDC and National Jewish Health that show bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. These results build on previous evidence from Europe that suggests the bacteria contaminated these devices during manufacturing in Germany.

The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. In the environment, M. chimaera rarely makes healthy people sick. Patients who have been exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that can often take months to develop. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat. There is no test to determine whether a person has been exposed to the bacteria.



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INFECTED MEDICAL DEVICES LEGAL ARTICLES AND INTERVIEWS

Stockert 3T Heater-Cooler System: A Condensed Time Frame
Stockert 3T Heater-Cooler System: A Condensed Time Frame
November 16, 2016
Philadelphia, PA: If a medical device isn’t recalled, chances are you won’t know it’s defective until research has been published, and then attorneys create an awareness. Sometimes the FDA sits on adverse event reports for years before warning the public. Case in point: the Stöckert 3T heater-cooler system. The FDA has been getting adverse event reports about the 3T since early 2010, but it only recently issued a public warning [READ MORE]


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