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Health Care FMEA Example Page 6
Health Care FMEA Example
Page 6 - Institute for Safe Medication Practices
Processes &
Failure Modes Causes Effects Severity
Actions to Reduce
Failure Mode
Administration (cont’d)
Program pump Pump mis-
programmed (flow
rate, concentration,
lock out, loading
Design flaw in pump (e.g.,
Abbott LifeCare PCA pump)
which makes programming
error-prone; lack of standard
concentrations; failure to limit
variety of products used;
knowledge deficit; confusion
between units of measure (mg
vs. mcg); mechanical failure
Overdose; under-dose;
poor pain control
4 3 12 Purchase pumps that are easy to
program: use FMEA process to
determine potential failure
modes of pumps to guide
purchasing decisions; limit
variety of pumps; train staff on
use of new pumps; minimize
variety of products used for
PCA; standardize
concentrations used; PCA
protocols; independent double
check at bedside
pump settings
Check not
Check inadequate
Same as above;
environmental factors
(distractions, space, lighting,
noise); inefficient workflow;
human factors; check not
completed at bedside (to
ensure check of pump
settings, patient, line
Inadequate staffing patterns;
lack of making the check a
priority; previous successful
violations; check process not
integrated into the way care is
Potential error not
detected and likely to
reach the patient
Same as above
Adequate staffing patterns;
engaging staff in culture of
safety; understand causes for
prior successful violations and
take action to eliminate barriers
to consistent checks; build
check processes into the care
delivery model in use
As above; environmental and
workflow improvements;
mental warm-ups before
checking to increase task focus;
use of verbal checks; check
performed at bedside
Administer PCA Wrong patient
Failure of double check at
bedside; failure to
check/absent name bracelet;
ordered on wrong patient;
/transcribed on wrong MAR
Overdose, under-dose;
allergic response;
ADR; delay in therapy;
poor pain control
3 3 9 As above under
“medication/pump settings
checked” section; match patient
therapy with condition; patient
© Institute for Safe Medication Practices 2005
Note: Hypothetical FMEA for typical hospital using patient controlled analgesia. Specific hospital issues and hazard scores will differ at each practice location
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