OBJECTIVES: Although isolated case reports have documented operator programming errors associated with intravenous patient-controlled analgesia (IV PCA) infusion pumps, no systematic analysis of IV PCA-associated problems has been performed. The objective of this study was to use the Manufacturer and User Facility Device Experience (MAUDE) database, a large publicly available database maintained by the US Food and Drug Administration (FDA), to characterize the types of problems associated with the use of IV PCA infusion pumps. METHODS: We extracted all IV PCA-related MAUDE case reports from January, 2002 through December, 2003. Reported causes of events were abstracted and classified as: possible operator errors (eg, pump programming errors); possible patient-related events (eg, patient tampering), possible device-related events (eg, device malfunctions), possible adverse drug reactions, and indeterminate events (unspecified causes). RESULTS: We found 2009 unique IV PCA-related reported events. Number of events increased from 455 in 2002 to 1554 in 2003, although the FDA instituted no corresponding changes in reporting requirements or data collection during these two years. Among all IV PCA-related reports, 79.1% (N=1,590) were possible device-related events, 6.5% (N=131) were possible operator errors, 1.2% (N=25) possible adverse drug reactions, 0.6% (N=12) possible patient-related events, and 12.6% (N=251) were indeterminate events. The device manufacturer confirmed 61% of the reported possible device-related events. CONCLUSIONS: Previously published single case reports of problems with IV PCA infusion pumps highlight operator error. Our analysis of the MAUDE data suggests, however, that nearly 80% of reported problems were attributable to possible device-related events. Although reporting bias may contribute to the high rates of possible device-related events (ie, operator errors may be reported as device-related events), more than half of the possible device-related malfunctions were confirmed upon manufacturer inspection. To our knowledge, this is the first study to use a large, retrospective database to examine IV PCA-related problems.