If you suspect a problem with an infusion pump, we encourage you to file a report with FDA. Here are some examples of problems with infusion pumps.
Healthcare Professionals and Consumers:
We encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Manufacturers, Importers and Device User Facilities
Manufacturers, importers and device user facilities are subject to separate mandatory reporting requirements.
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices.
What to Include in a Report:
To help us learn as much as possible about the adverse events or problems associated with infusion pumps, please include the following information, if available, in your reports:
- Details about the infusion pump failure or malfunction
- Any medication or fluids that were infusing at the time of the event
- If a new pump or another method of infusion had to be utilized in order to continue the infusion
- Any information displayed on the pump
- If an audible/visual alarm was generated
- Any relevant patient or user information including:
- If a medication had to be increased, decreased, or placed on hold
- If additional medication or fluid was administered as a result of an infusion pump issue
- If additional blood work or lab work had to be drawn as a result
- Changes in vital signs, etc.
- If the pump has been evaluated, and the evaluation results, if applicable
- Device identifying information, including model/catalog number and serial number
If you have questions about Medical Device Reporting, including interpretation of MDR policy:
- Email: MDRPolicy@fda.hhs.gov
- Or write to: Food and Drug Administration
Center for Devices and Radiological Health
Reporting Systems Monitoring Branch
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Silver Spring, MD 20993-0002
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