Medical Devices
Infusion Pumps
| Report an Infusion Pump Problem |
External infusion pumps are medical devices that deliver fluids, including nutrients and medications such as antibiotics, chemotherapy drugs, and pain relievers, into a patient’s body in controlled amounts. Many types of pumps, including large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps, are used worldwide in healthcare facilities such as hospitals, and in the home.
Clinicians and patients rely on pumps for safe and accurate administration of fluids and medications. However, FDA has identified problems that can compromise the safe use of external infusion pumps. These problems can lead to over- or under-infusion, missed treatments, or delayed therapy.
FDA is taking steps to address infusion pump problems through the Infusion Pump Improvement Initiative. (For more information, see the FDA’s White Paper.)
On this website, you can learn more about infusion pump problems, actions FDA is taking to improve pump safety, strategies to reduce pump-related risks, and steps you can take to report problems to FDA.
Links
- Nursing2011 Article: "Smart" Infusion Pumps are Selectively Intelligent
AAMI and FDA Summit on Infusion Devices, Oct 5-6, 2010: Speaker Presentations 
Presentation: Top 13 Priorities for Improving Infusion Device Safety
White Paper: Infusion Pump Improvement Initiative Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Letter to Infusion Pump Manufacturers Public Meeting: Infusion Pump Workshop, May 25-26, 2010 Generic Infusion Pump Project
Federal Register: Infusion Pumps; Public Meeting; Request for Comments Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions; Availability
Baxter Colleague Recall, Refund, and Replacement Action
Baxter: Certificate of Medical Necessity (CN) Due November 14, 2010
FDA's Final Order to Baxter to Recall, Refund, or Replace the Colleague Infusion Pumps Questions and Answers About the Baxter Colleague Recall, Refund, and Replacement Action FDA Issues Requirements for Baxter Healthcare Infusion Pump Recall [ARCHIVED]
