FDA 483 - Edwards Lifesciences, LLC - June 14, 2019

Edwards Lifesciences, LLC in Irvine, CA, received a Form 483 with three observations related to its quality system for medical devices. The inspection revealed deficiencies in corrective and preventive action procedures, process controls for software problems, and complaint handling processes. These issues are serious as they relate to patient safety, specifically concerning the EV1000 Clinical Platform hemodynamic monitoring system experiencing fires due to liquid ingress and unaddressed software defects.