Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation
Highlights
- • We analyzed MAUDE database to assess ECMO devices' reported adverse events.
- • Most common patient-related events were hemodynamic decompensation and death.
- • Most common failure modes were mechanical pump and membrane oxygenator.
- • Standard reporting may improve safety and effectiveness of ECMO devices.
Abstract
Background/Purpose
We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited.