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Infusion device incidents Lessons learned and recommendations
Jason Ng, Andy Chung, Bonnie Wong, Becky PY Ho, Kate Choi, Anne Kwan, Joseph Lui, Fred Chan, Ella Ma, David Lau, Lilian Lau
HA Convention 8HA Convention 8thth May 2007May 2007
Introduction – Infusion device
• Often employed to infuse fluids, nutrients, or medication into patient’s circulatory system
• Widely used for safe and accurate administration
Safety of the infusion device
• Improper use of the equipment can be potentially dangerous or even life-threatening
Aim of study
• Lack of local data addressing on the safety issue of infusion device
• 1) review the characteristics of the adverse incidents
• 2) recommend appropriate actions to enhance the safe use of infusion device
Method
• Working Group on Safe Use of Infusion Pump
• Risk managers of the clusters reported medical incidents
• Advanced Incident Reporting System(AIRS).
• Electrical and Mechanical Services Department (EMSD) for checking.
2 Stages
• 1st :KCC, NTEC, NTWC• 2nd :All clusters (HKEC, HKWC,
KCC, KEC, KWC, NTEC, NTWC)
Result
• Period: January 2005 to Sept 2006 • 70 incidents • related to the use of infusion device
Types of Infusion device• 59 Infusion pumps • 11 Infusion syringes
RESULTSWhat had been given?
How severe were the incidents? Who were involved?
Which steps were involved?Why did they happen?
Results
RESULTSWhat had been given?
How severe were the incidents? Who were involved?
Which steps were involved?Why did they happen?
Results
What had been given?
• 9 were used for intravenous fluid replacement
• 61 infusion devices were used for administering medication
• Most medications were used for – cardiovascular system
• e.g. thrombolytic agent, vasodilator, vasopressor
RESULTSWhat had been given?
How severe were the incidents?Who were involved?
Which steps were involved?Why did they happen?
Results
Severity IndexSI = 0
Incident occurred but stopped
beforereaching patient.No consequence.
SI = 1Incident occurred
but no injury sustained.
SI = 2Minor injury
SI = 3Temporary
morbidity
SI = 4Significant
Morbidity
SI = 5Major permanent
loss of function / disability
SI = 6 Death
May have required monitoring.
No investigation is required
Required monitoring
&/or investigation
Required monitoring
&/or investigation.
Required transfer to a higher care level.
No change in vital signs.
Some changes in vital signs.
Significant changes in
vital signs.
No treatment required.
Required minor treatment
(e.g. simple wound care, analgesic).
Required simple treatment
(e.g suturing).
Required emergency treatment /
surgical intervention.
Severity Index of the Incidents
05
101520253035404550
0 1 2 3 4 5 6
Severity Index
No. of incidents
RESULTSWhat had been given?
How severe were the incidents?Who were involved?
Which steps were involved?Why did they happen?
Results
WHO were involved?
05
101520253035404550
Nurse MO HO Others
No. ofincidentsinvolved
RESULTSWhat had been given?
How severe were the incidents? Who were involved?
Which steps were involved?Why did they happen?
Results
Infusion steps
Prescription Setting up infusion rate
Device operation
Calculation
Administration Device tampering
23 incidents
11 incidents
RESULTSWhat had been given?
How severe were the incidents? Who were involved?
Which steps were involved?Why did they happen?
Results
WHY did they happen?
Human factorDevice factorUnknown
Factors Human factorsDevice factors
Causes of incidentsHuman factors
0 5 10 15 20 25
Human Factors
Misunderstanding device
Incorrect set up
Device tampering
Calculation errors
Failure to deliver
Wrong consumables
Wrong administration
Wrong set up (23/70)
9
10
Intended setting
99
Actual setting
1
Wrong set up• 3 incidents• Swab between 2
infusion settings
Lack of understanding of device operation (11/70)
• Free flow– administration set had been
removed from an infusion pump– roller was not clamped before
opening door (in some models)• Persons involved
– e.g. nurses, health care assistant, radiographer
• Circumstance• e.g. transferal of patient
Factors Human factorsDevice factors
Causes of the incidentsDevice Factors
0 2 4 6 8
Device factors
Device Design
Device Defect
Device factors (14/70)• Device defect• 7 incidents
– Defective pump– Defective alarm– Damaged electric cord
• Device design• 7 incidents
– Lack of anti-free flow protection
Device design - Free flow
• 7 incidents (7/70)• Models: Drip rate type infusion
– E.g. Dropmat, Dripwatch, Nikkiso• Mechanism: Free flow occurred
when the door was opened without clamping the roller
• Precaution: Not suitable for high risk medications
Device without built in anti-free flow mechanism
Risk Management of Infusion PumpRisk Management of Infusion Pump
Recommendation
Recommendation 1
• Training– To provide adequate education and
training to staff.– Formal demonstration of commonly
used models should be arranged.
Human factors
Recommendation 2
• Safe alert– The awareness of the safety issue on
infusion device should be raised– Ensure 3 checks 5 rights– Periodic assessment on the skill and
knowledge about operating infusion device may be required.
Human factors
Recommendation 3 Device factors
• Include built-in free-flow protectionas standard in the specification in future procurement
• Require timely and appropriate action on high-risk models e.g. removal from service, safety modifications, add safety tags
High-risk models
Recommendation 4
• Standardization of the infusion device to a few models– avoid confusion– promote user training, equipment
maintenance– share equipment library and
consumable supply
Less is more
Significant injury1
69 Mild injury
Near Miss??Mild / Severe event
Limitation 1: Underreporting
Limitation 2 • Simplistic analysis
– Human vs Device factor
• Reality– Multifactorial– Consider other factors
• Staff experience • Ward circumstance• ….
Conclusion
• 70 incidents related to infusion device were captured in 21 months
• Identify – High risk steps – High risk models with no free flow
protection • Error prevention strategy
Conclusion
• Proof of concept• Useful data retrieved from AIRS
– Lessons learned – Make recommendation
Safe Culture
Just culture
Reporting culture
Flexible culture
Sharing and
learning culture
Learning and sharing
It takes a wise man to learn from his mistakes,but an even wiser man to learn from others
Acknowledgement
• Dr Lilian Lau • Mr Andy Chung• Ms Bonnie Wong• Ms Becky PY Ho• Ms Kate Choi• Mr Kennis IP• Dr MY Cheng
• Dr David Lau • Dr Anne Kwan• Dr Joseph Lui• Mr Fred Chan• Ms Jayne Lee• Mr YL Cheung• Ms Ella Ma
Working Group on Safe Use of Infusion Pump
Thank you
Classification Incidents Possible causes
Follow up actions
No. of cases
Incorrect infusion rate setting by users
Wrong infusion rate
Wrong input Staff trainingBuilt-in safety mechanism
5
The use of incompatible consumables
Wrong syringe used for patient controlled analgesia
Use other brand of syringe
Staff trainingStandardize device
4
Lack of understanding of the device operation
Infusion was finished earlier than expectedwith free flow of fluid
Lack of understanding of device operation leading to free flow infusion
Staff trainingReplace high risk modelsBuilt-in safety mechanism
3
Human Factors
Over infusion of IVF to a neonate
Wrong calculation of prescription
Staff trainingStandardize IVF
Over infusion of drug
Wrong calculation of infusion rate
Staff training Standardize drug concentration
Over infusion rate Wrong drug label interpretation
Staff training
3Calculation errors
No. of cases
Follow up actions
Possible causes
Incidents Classification
Human Factors
Battery ran out without power to run the syringe
Staff was not aware of short life duration (4 days)
Reminder staff to use new battery for new set-up or check battery level before use
Syringe driver not in proper position
Staff was not familiar with the set up of infusion pumpLack of monitoring
Staff training
Device tampering Over infusion Tampering Proper placement of infusion device
1
2Failure to deliver drug
No. of cases
Follow up actions
Possible causes
Incidents Classification
Human Factors
Classification Incidents Possible causes
Follow up actions
No. of cases
Drug was not infused
Defective pump syringe
Periodic check by EMSDPump syringe was repaired
Over infusion of the drug
Defective sound blast of pump syringe
Periodic check by EMSDSound blast of pump syringe was repaired
2Infusion device fault
Device Factor
Root cause analysis
Events
System factorsProximate causes
Content
• Introduction• Aim of study• Method • Result• Recommendation• Discussion• Conclusion
Limitation 2
• AIRS version 2 • Infusion device template NOT
AVAILABLE– Free text– Information may be missing
Device tampering (7/70)• Under infusion• 5 incidents• Nurses• Forget to resume
setting after reset
• Over infusion• 2 incidents• Patients• Change setting
accidentally
