From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps. Of these, approximately 1% were reported as deaths, 34% were reported as serious injuries, and 62% were reported as malfunctions.

Infusion pumps have contributed to improvements in patient care, allowing for a greater level of control, accuracy, and precision in drug delivery, and thereby reducing medication errors. At the same time, like other medical devices, infusion pumps are not without risks. FDA has received numerous reports of adverse events associated with the use of infusion pumps, including serious injuries and deaths. From 2005 through 2009, 87 infusion pump recalls were conducted by firms to address identified safety problems.

Infusion pump problems have been observed across multiple manufacturers and pump types. Through analysis of pump-related adverse event reports and device recalls, FDA has concluded that many of these problems appear to be related to deficiencies in device design and engineering. FDA has seen an increase in the number and severity of infusion pump recalls.

The most frequently reported external infusion pump device problems are: software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown”. Subsequent root cause analyses revealed that many of these design problems were foreseeable and, therefore, preventable.

Other reports: In 2000, the Institute of Medicine published a report that stated from 44,000 to 98,000 deaths occur yearly due to medical errors, making medical errors the eight leading cause of death in the United States. The report identified medication errors as the most common type of error. 7000 deaths annually were attributed to medication errors.