Posts Tagged 'heater-cooler'

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 Lawsuits Filed in Pennsylvania

2 Pennsylvania heater-cooler lawsuits filedTwo Pennsylvania residents have filed a lawsuit against the University of Penn Health System claiming that they contracted dangerous bacterial infections because of defective heater-cooler units, or HCUs, according to a recent philly.com report.

The plaintiffs, Robert Gerngross and Marisa Karamanoogian, would be among the latest claiming to suffer from such infections. The FDA has now received notice of more than 80 cases worldwide. More than 25% of those are ...

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Eyes Turn to Delays at FDA Over Heater-Cooler Infection Blame

fda delayed for years on heater-cooler risksWhen it comes to keeping you and your family safe, most Americans would agree that they’d like to think that the agencies with that responsibility are ready to act on their behalf. That, when a problem arises, they will correct the issue and move to solve it quickly and decisively. Not only will they know what needs to be done, but they will do it when it matters most.

By all ...

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Numbers Emphasize Scope of Heater-Cooler Risks

600,000 surgeries may have occured with heater-cooler in roomThe warnings had been increasing in their severity since the first infections hit. When the FDA initially noted a link between heater-cooler systems and nontuberculous mycobacterium, or NTM, infections, the agency started with a generalized list of precautions to follow to reduce the risk of those infections. Eight months later, an additional Safety Communication was released. And then, four months after that, the FDA named a ...

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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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