The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database

Abstract

ABSTRACTBackground: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system.Methods: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016.Results: Of 1,430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law.Conclusion: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.