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Miscategorization of Deaths in the US Food and Drug Administration Adverse Events Database
As the US Food and Drug Administration (FDA) moves to hasten approval of medical devices, data from postmarketing studies and registries are increasingly relied on to inform decision-making.
Elimination of CO2 Insufflation-Induced Hypercapnia in Open Heart Surgery Using an Additional Venous Reservoir
An additional venous reservoir for the evacuation of blood from the open surgical wound eliminates CO2 insufflation-induced hypercapnia in open heart surgery keeping PaCO2 and sweep gas flow constant. This prevents possible CO2-induced hyperperfusion of the brain and decreases the risk of cerebral particulate embolization during CO2 insufflation for de-airing in open heart surgery.