Infusion Pump DFMEA
An infusion pump DFMEA focuses a design review on faults that can change or interrupt therapy. Break the device into functions such as measuring flow, powering portable use and alerting the user to an occlusion. For each function, the worksheet connects a failure mode to a patient or treatment effect, its technical cause and the controls already designed into the product. High-severity effects deserve careful review even when the estimated occurrence is low. This example includes sensor drift, connector vibration, battery aging and a speaker circuit fault. It is not a substitute for a medical-device risk-management file or verification plan. Instead, it gives the cross-functional team a concise way to record design assumptions and decide which safeguards need stronger evidence.
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Scenario
A medical-device team is reviewing hazards in an infusion pump design.
Key decisions
- Flow accuracy: Define calibration limits and test at startup.
- Connector retention: Test vibration resistance and detect disconnection.
- Battery warning: Alert users before remaining capacity stops therapy.
- Alarm audibility: Verify the speaker path during self-test.
When to reuse this
Use this DFMEA to structure early design discussion; a medical device needs its own documented risk-management process.
Frequently asked questions
What is an infusion pump DFMEA?
Why is severity high for excess medication?
Does a DFMEA replace medical-device risk management?
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