Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
An ambulatory infusion pump is a portable or wearable pump that delivers fluids, such as nutrients and medications, into the body in controlled amounts while the person moves about. This page explains what the FDA says about the product class, what a pump of this kind can be set to deliver, and the safe-use habits the FDA lists. Clinic staff, home-infusion teams, supply buyers and students are the usual readers.
What an ambulatory infusion pump is
The FDA defines an infusion pump as a medical device that delivers fluids, such as nutrients and medications, into the body in controlled amounts. It lists several types: large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral and insulin pumps. It then adds that “others, called ambulatory infusion pumps, are designed to be portable or wearable.” The defining feature is therefore portability, not a particular drug or route. For the wider category, see what an IV infusion pump is.
Who uses it: people who receive scheduled or continuous infusions outside a fixed bedside setup, and the clinicians, pharmacists and home-infusion suppliers who set up and support those pumps.
What it delivers and how it is operated
The FDA’s description of one widely used ambulatory pump family shows the range of what the class can be programmed to do. The table below is limited to what the FDA states on its CADD-Solis recall page (last updated 6 August 2024); it describes one product family, not every ambulatory pump.
| Feature | What the FDA states |
|---|---|
| Delivery pattern | Continuous infusion rates, an intermittent larger dose (bolus), and patient-controlled dosing. |
| Where fluids can be directed | Into blood vessels, under the skin, into the abdomen, near nerves, into surgical sites, and into epidural or subarachnoid spaces. |
| Safeguards named in the notice | Alarms (including upstream occlusion and single-bubble alarms), an air detector, and stop and power keys. |
| Software | Pump software and a connected server application (PharmGuard) that must be kept current. |
The FDA’s general infusion-pump page lists the substances an infusion pump may deliver, including insulin or other hormones, antibiotics, chemotherapy drugs and pain relievers. Which one applies to a given person is a prescriber’s decision and is outside the scope of this page.
Ambulatory pumps compared with other pump types
The FDA names these types side by side: large volume, PCA, elastomeric, syringe, enteral and insulin pumps, plus ambulatory pumps. For an example of a wearable insulin pump, see what the Omnipod is. The FDA does not give a spec sheet for the class as a whole, so the manufacturer’s instructions for use for the exact pump are the reference for what it can do. Related reading: infusion sets, rapid infusers and the outpatient infusion center supply checklist.
A worked example: the 2024 CADD-Solis software correction
In 2024 the FDA posted a recall notice for CADD-Solis ambulatory infusion pumps and related software. It is a useful example of why software version and alarms matter in this class. All details below are from the FDA notice.
| Product named | Affected software, per the FDA |
|---|---|
| CADD-Solis ambulatory infusion pump | Various software versions earlier than v.4.2 |
| CADD-Solis VIP | Versions earlier than v.1.6 |
| PharmGuard server software | Versions earlier than v.2.6 |
The FDA lists problems including failure to alarm when there is an upstream occlusion, unresponsive stop or power keys, an air detector that did not start in manual mode, and missing single-bubble alarms. The manufacturer’s urgent letter is dated 27 February 2024. The FDA classified it as the most serious type of recall (Class I) and noted that it is a correction, not a removal, with one injury and no deaths reported. The FDA’s instruction: make sure the most recent CADD software is installed on all pumps.
Safe use and handling basics
These points come from the FDA’s page “Infusion Pumps: Tips for Using Your Pump at Home”. They are general and do not replace the training and instructions for the specific pump.
- Complete training on safe use of the pump, and do not begin using it if the training has not answered all your questions.
- Understand the alarms and error messages and what to do if they appear. Do not ignore alarms.
- Check tubing for leaks, kinks, twists and disconnects.
- In some cases, batteries should be used for back-up only. Always keep an extra supply of new batteries with you.
- The FDA says to contact the pump company or a health care provider with questions.
The FDA’s general page notes that infusion-pump safety problems can lead to over- or under-infusion, missed treatments or delayed therapy, and that the commonly reported problems are software defects, user-interface issues, and mechanical or electrical failures.
Common mistakes
- Silencing or dismissing an alarm without understanding it.
- Not looking at tubing for kinks, twists, leaks or disconnects.
- Running out of spare batteries.
- Leaving pump or server software out of date after a manufacturer correction.
- Starting use before training has answered every question.
Frequently asked questions
What is an ambulatory infusion pump?
It is an infusion pump designed to be portable or wearable, according to the FDA. Like other infusion pumps it delivers fluids, such as nutrients and medications, into the body in controlled amounts.
How is it different from an IV pump in a hospital room?
The FDA’s distinction is that ambulatory pumps are designed to be portable or wearable. The routes and delivery patterns depend on the specific pump and its instructions for use.
How are pump problems reported?
The FDA says problems are reported to the health care provider, the pump supplier and the FDA, which lists 1-800-332-1088 (24 hours a day) for reports.
Where can I see product categories?
Product listings are available in the infusion pumps category at lac.us.
Sources
- U.S. Food and Drug Administration, Infusion Pumps (checked 30 October 2026).
- U.S. Food and Drug Administration, Infusion Pumps: Tips for Using Your Pump at Home (checked 30 October 2026).
- U.S. Food and Drug Administration, Ambulatory Infusion Pump Software Correction: CADD-Solis and CADD-Solis VIP, page updated 6 August 2024 (checked 30 October 2026).
