• Oluwadolapo D Lawal, Maitreyee Mohanty, Harrison Elder, Margie Skeer, Nathalie Erpelding, Ryan Lanier, and Nathaniel Katz.
• a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
• Expert Opin Drug Saf. 2018 Apr 1; 17 (4): 347-357.

BackgroundThe 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.MethodsWe 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.ResultsOf 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.ConclusionPatients 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.

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