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U.S. Department of Health and Human Services

Medical Devices

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Reporting Problems with Infusion Pumps

Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices.

If you suspect a problem with an infusion pump, we encourage you to file a report with FDA. Click here for 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.

User Facilities:

Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Device Manufacturers:

Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

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:
    1. If a medication had to be increased, decreased, or placed on hold
    2. If additional medication or fluid was administered as a result of an infusion pump issue
    3. If additional blood work or lab work had to be drawn as a result
    4. 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 the Medical Device Reporting (MDR) Regulation, Including Interpretation of MDR Policy:

  • Email: RSMB@fda.hhs.gov
  • Call: (301) 796-6670 (voice)
  • Or write to: Food and Drug Administration
    Center for Devices and Radiological Health
    Reporting Systems Monitoring Branch
    10903 New Hampshire Avenue
    WO Bldg. 66, Room 3217
    Silver Spring, MD 20993-0002