Posts Tagged 'sorin'

DNA Links Contaminated Heater-Cooler Units to German Factory

heater-cooler contamination linked to german factoryA study published in the Lancet Infectious Diseases journal has linked DNA from 250 samples of contaminated heater-cooler units, or HCUs, to the German manufacturer LivaNova and its Munich factory, according to reports from Kaiser Health News. The devices have been tied to more than 100 severe or fatal infections worldwide since 2013.

The samples were obtained from patients and matched to a group of the defective heater-coolers with ...

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Heater-Cooler Risks Could be Far More Severe than Originally Thought

CDC warns on heater-cooler useWhen doctors and researchers first discovered the link between heater-cooler devices and a bacterial infection, they thought they’d found the reason for a few patients falling ill after cardiothoracic surgery. However, as more information came to light, the implications – as well as the risks involved in using the devices – are growing far beyond those initial concerns.

The U.S. Centers for Disease Control recently issued a warning of those risks. ...

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Philadelphia Lawsuit Filed Over Heater-Cooler Device

philadelphia heater-cooler contamination filedA heater-cooler contamination lawsuit has been filed in Philadelphia Court of Common Pleas. The plaintiff, a Philadelphia man, alleges the heater-cooler device used by surgeons at Penn Presbyterian Medical Center exposed him to bacteria resulting in him suffering a slow growing infection and eventual stroke. The heater-cooler devices used during open heart surgeries and the methods used to clean them are coming under increasing scrutiny by health officials.

The plaintiff in the Philadelphia lawsuit underwent ...

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FDA Panel Investigates Heater-Cooler Role in Infections

fda investigating heater-cooler blanketsThe FDA’s Circulatory System Devices Panel met earlier this year to hear from scientists and clinicians over concerns that heater-coolers used in cardiac surgeries may be contributing to an increased risk of patient infection. If a definitive link is found, it could bring significant changes in the way the devices are used in these procedures.

Cardiac surgery is serious. Opening a patient’s chest and operating on their heart is a task reserved ...

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