Health Care FMEA ExampleHealth Care FMEA ExampleHealth Care FMEA Example
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Institute for Safe Medication Practices

Example of a Health Care Failure Mode and Effects Analysis for IV Patient Controlled Analgesia (PCA)
Processes &
Subprocesses
Prescribing

Failure Modes

Causes

(what might happen)

(why it happens)

Effects

Severity

Probability

Hazard
Score

Actions to Reduce
Failure Mode

Assess patient

Inaccurate pain
assessment

Cultural influences; patient
unable to articulate

Poor pain control

2

4

8

Choose
analgesic/mode
of delivery

Wrong analgesic
selected

Improper dosing;
improper drug; allergic
response;
improper use of
substitute drug

4

3

12

Prescribe
analgesic

Wrong dose
(loading, PCA,
constant, lock-out),
route, frequency

Clinical situation not
considered (age, renal
function, allergies, etc.);
tolerance to opiates not
considered; standard PCA
protocols not followed (or not
available); concomitant use of
other analgesics not
considered; drug shortage;
knowledge deficit; improper
selection of patients
appropriate for PCA
Knowledge de