“Create a design FMEA for an infusion pump. Cover a low-reading flow sensor from sensor drift causing excess medication, a disconnected sensor from connector vibration interrupting therapy, an aging battery stopping infusion early, and an inaudible occlusion alarm from a speaker fault. Include calibration, retention, startup, connection, remaining-time and audible-alarm checks.”
看懂背後的決策。
Define calibration limits and test at startup.
Test vibration resistance and detect disconnection.
Alert users before remaining capacity stops therapy.
Verify the speaker path during self-test.
Use this DFMEA to structure early design discussion; a medical device needs its own documented risk-management process.
常見問題
What is an infusion pump DFMEA?
It is a design FMEA that examines pump functions, failure modes, effects, causes and controls before verification.
Why is severity high for excess medication?
An incorrect delivered dose can cause serious patient harm, so its effect warrants a high severity rating.
Does a DFMEA replace medical-device risk management?
No. It can support design analysis, but it does not replace the documented risk-management activities required for a device.