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FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.
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A Failure Mode Effect Analysis on Extracorporeal Circuits for Cardiopulmonary Bypass
Although many refinements in perfusion methodology and devices have been made, extracorporeal circulation remains a contributor to neurological complications, bleeding coagulopathies, use of blood products, as well as systemic inflammatory response.
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A Hemolysis Study of an Intravascular Blood Cooling System for Localized Organ Tissue Cooling
To assess initial blood safety of our new organ cooling system, the CoolGuide Cooling System (CCS), we investigated safe operating conditions and configurations from a hemolysis perspective.
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