
Abstract
Failure of extracorporeal membrane oxygenation (ECMO) circuit components can precipitate abrupt hemodynamic or respiratory collapse; however, the evidence linking specific component malfunctions to patient harm remains sparse, and device-specific analyses are lacking.1-3 The US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database is a repository for the mandatory reporting of complications associated with regulated medical devices.4 In a previous analysis that compared reported malfunction frequency and injury across durable and disposable components of the ECMO circuit, we found that ECMO pump/control console‒related events represented an increasingly important proportion of reported failures. However, this component-level approach did not adequately resolve how these devices fail or whether specific failure modes differ in their association with patient harm.5 In this study, we characterized recent patterns of pump/console-related reports in MAUDE database, evaluate their association with reported patient harm, and identify postmarket safety signals that may warrant continued surveillance. Data were obtained from the MAUDE database from January 2021 through December 2025 and included reports involving devices classified as “Blood pump for ECMO, long-term (>6 hours) use.” The database was accessed on January 21, 2026. Because one adverse event may generate separate reports for multiple devices, the individual report served as the unit of analysis for device-level characterization. Duplicate reports describing the same event were consolidated into unique events for patient-level analyses. Each report’s device problem was classified into a predefined malfunction category, and clinical consequences were assigned through manual review of the narrative description by clinician investigators. Continuous variables are reported as medians (interquartile range) and categorical variables as counts (%). Associations between malfunction category and reported harm (injury or death) were evaluated by Fisher exact test, with odds ratios (ORs) comparing each category against all others and Benjamini-Hochberg adjustment for multiple comparisons.
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