[ SCENARIO · FREE · DETERMINISTIC ]
Complaint to CAPA
A clinician reports that an infusion pump alarmed and stopped mid-therapy. Take it from complaint intake through investigation, reportability, and the risk file — and see whether the post-market loop actually closes.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
A hospital says a device did something it should not. What you do next decides whether anyone learns from it.
A complaint must be investigated, assessed for reportability, trended against history, and fed back into the risk file and design when the signal warrants it.
Post-market surveillance is the organisation’s hearing. A signal missed here becomes a field action later, and the record of what you noticed is the defence.
You are a complaint and vigilance specialist. A clinical engineer reports an infusion pump that alarmed and stopped mid-therapy. The patient was not harmed. The device has been returned.
Nothing here is a trick. Choose what a controlled post-market system would actually do — the situation changes based on your choice.
The report is brief: "pump alarmed and stopped, patient fine". You have the device and the clinician’s phone number.
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across investigation · reportability · risk · systemic — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
- 21 CFR 820.10 — Quality Management System Regulation: a QMS meeting ISO 13485 (effective 2 February 2026) ↗
- 21 CFR 820.35(a) — records of complaints, in addition to ISO 13485 clause 8.2.2 Complaint Handling ↗
- 21 CFR 803.50 — manufacturer medical device reports, due within 30 calendar days of awareness ↗
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
KEEP PRACTISING
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