Incident Data: Filling the Gaps, Identifying the Value...

Incident Data: Filling the Gaps, Identifying the Value, and

Prioritizing Needed InformationPat Baird

[email protected]

October 6th, 2010

Goal:• Look for patterns in the public data to know where to dig for additional investigation

• Goal is not to repackage or assess any single complaint – instead, look for commonalities

Meet this by:• Look at relative (not absolute) numbers• Look for contributors to Harm• Look for which safety system failed

2

Presentation Overview

• Methodology

• Literature Review

• Analysis Results by Device Type

• Recall Review

• Results Summary

• Open Discussion

3

Presentation Overview – Detailed

• Methodology– Approach– Types of Data Collected– Problems Encountered

• Literature Review• Analysis Results by Device Type• Recall Review• Results Summary• Open Discussion

4

Review Approach

• Look for broad patterns of harm

• Use public data sources– Literature / Conference Proceedings

– Manufacturer and User Facility Device Experience (MAUDE)

– FDA Class I Recall list

5

Review Approach – Recalls & Lit

• Literature / Conference Proceedings– Examined 10 years of papers regarding the causes of Harm, but not papers of recommended solutions

• FDA Class I Recall list– Examined 5+ years of Class I recalls for infusion devices

6

Review Approach – MAUDE

• Manufacturer and User Facility Device Experience (MAUDE)

• 3 year review: 1/1/2007 – 12/31/2009

• All Product Types in Guidance – except Insulin

• All manufacturers

• Death & Injury only, excluded malfunctions

7

Data Collected ‐ Asking the 5Ws + HWhoAge – Adult, Child

WhatOutcome – Death, Injury

WhenPhase – Setup, Programming, Running, Handoff, Teardown…

WhereCare Area – ICU, L&D, Home…

Drug Family – Vasoactive, TPN, Insulin...

Where (contd)Device Type – Syringe, Ambulatory, LVP, PCA…

Device Configuration – Single, Multiple channel device

HowHazardous Situation – Over Infusion, Under Infusion, Free Flow, Interruption…

WhyCause – Failure, Use Error, Amount/Concentration Slip...

8

Additional Data Collected

• Was there a drug library limits warning noted?

• Was there a 2nd clinician verification step noted?

• Was the device evaluated?

• Was the device’s internal log reviewed?

9

Sidebar: Measurement System Analysis & MAUDE Reporting

There is variation any time you go to measure something.

How repeatable and reliable do I need my measurement system to be?

Is MAUDE an acceptable measuring tool?

What are the alternatives?

10

11

EVENT DESCRIPTIONThe customer contact reported an adverse event while the device was in use. On an unspecified date and time, the device was programmed to deliver an unspecifiedpain medication via an intrathecal catheter and the delivery was started. No specific programming parameters were provided. After an unspecified length of time, the nurse found the patient "face down in bed unresponsive" and a code was initiated. The device was removed from clinical service. During testing at the user facility, the customer contact reported the device passed testing. Multiple unsuccessful attempts were made for additional event information. If additional information is obtained, a follow up report will be submitted.

Complicating Factors

• MAUDE is a self‐report system, records might not contain all necessary information

• Misclassification – 15% of reports about PCA devices were found in General Purpose

• MAUDE only covers device‐related issues –issues with misconnections, pharmacy errors, drug interaction, etc., will not show up

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• Methodology



• Recall Review

• Results Summary

• Open Discussion

13

Literature Review ‐ Challenges

• Case reports are about specific incidents, not broad categories

• Conference proceedings often made best practice recommendations ‐ but those are solutions for unstated problems.

14

“Patient Safety Issues With Patient‐Controlled Analgesia“ [D’Arcy]

A hospital’s review of 56 PCA‐related events showed the sources of error as:

• PCA programming 71%

• Human factors / wrong meds: 15%

• Equipment problems 9%

• Ordering errors 5%

15

“Patient Safety Issues With Patient‐Controlled Analgesia“ [D’Arcy] – cont’d

Common programming errors include:• Confusion over milligrams and milliliters• PCA bolus dose being confused with the basal rate

• Loading dose programmed as a bolus dose• Wrong lockout selected• Wrong medication concentration entered

16

“Parenteral Medication Errors” [Santell]

Presented at the 2008 ASHP IV Safety Summit.

A review of the MEDMARX database 2002 –2006 for parenteral errors.

126,596 parenteral errors

3,873 harmful parenteral errors

25 fatalities

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P.M.E. ‐ Top 10 Locations of Harmful Parenteral Errors

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Category MEDMARX % Running %Nursing Unit 49% 49%ICU 14% 63%Pharmacy 9% 72%ED 7% 79%Surgical Services 5% 84%Radiology 3% 88%Maternity/LD 2% 90%Oncology 2% 92%Long term care 1% 93%Outpatient Clinics 1% 94%

P.M.E. ‐ Top Therapeutic Categories most often Involved with Harmful Parenteral Errors

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Category MEDMARX % Running %Insulin 18% 18%Opiod Analgesics 17% 35%

Blood Coagulation Modifiers 9% 44%

Beta‐Lactam Antimicrobials 6% 50%

Electrolytes/Minerals 4% 54%

Anti‐Infectives(other) 3% 57%

Sedatives/Hypnotics/Anxiolytics 3% 61%

Autonomic Medications 3% 64%

Adrenal Corticosteriods 2% 66%Diuretics 2% 68%

Parenteral Med Errors ‐ Top Errors

20

CategoryMEDMARX

% Running %

Improper Dose/quantity 31% 31%

Omission 24% 55%

Unauthorized/wrong drug 12% 67%

“Adverse Events with Medical Devices in Anesthesia and Intensive Care Unit Patients Recorded in the French Safety Database in 2005–2006” [Beydon]

Reviewed 4,188 records in French AFSSAPS Database; 138 “Severe Events” involving infusion devices

21

Nature of Problem% of Severe

EventsError in infusion rate 24%Disconnection and migration in vascular bed 13%Significant vessel lesion during insertion 9%Unrecognized leaks with bleeding 7%


• Methodology• Literature Review• Analysis Results by Device Type

– MAUDE Review Metrics– 5 Ws + H for each Device Type

• Recall Review• Results Summary• Open Discussion

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Takeaways from MAUDE Review

In general: 1. Rarely was there any “Who”

2. Quality of report varied by device type

3. Death reports had minimal information; Injury reports had much more

4. FRN (General Purpose) devices had the most complete reporting

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3 yr Review Metrics by Device Type

Product Type # D & I Reports

# Unique D & I

# Injuries # D & PD

PCA (MEA) 160 128 112 16

Elastomeric (MEB) 498 189 185 4

Enteral (LZH) 58 40 37 3

General Purpose (FRN) 347* 238 181 57

Insulin Body Worn (OPP) 0 0 0 0

Insulin (LZG) Not Reviewed

Pump Accessory (MRZ) 0 0 0 0

Total 1063 595 515 80

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PCA MAUDE Data Review

Report Date 1/1/2007 – 12/31/2009Event Date 1/1/2007 – 12/31/2009

Product Code = MEADeath & Injury Reports

All Manufacturers / All Brands

160 D&I Reports / 128 Events Meet Criteria

PCA – What happened?

26

Death &PossibleDeath13%

Injury87%

Denominator: 128 Adverse Events

PCA – When did it happen?

27

Programming Pump34%

Unknown47%

Running 4%Global 7%Change 8%

PCA – How did it happen?

28

Over Infusion71%

Unknown 23%

Free Flow 5%Other 1%

PCA – Why did it happen?

29

Unknown42%

Use Error55%

Other3%

Why ‐ Use Error Detail

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1a# Type of Error %

1 “Right data, wrong field”

a. Drug/Dose Slip 32%

b. Volume/Concentration 3%

c. Rate / Concentration Slip

4%

2 Decimal Point Error 10%

3 Wrong Unit (“mL” vs “mg”) 7%

4 Manipulation Bolus 14%

5 Mis‐programming 23%

6 Other Use Error 7%

1b1c

234

5

6

Swiss Cheese Theory of Organizational Vulnerability [James Reason]

31

Graphics taken from:The Human Factors Analysis and Classification System–HFACS

The “Swiss cheese” modelof accident causationFebruary 2000

Scott A. Shappell FAA Civil Aeromedical InstituteOklahoma City, OK 73125 Douglas A. WiegmannUniversity of Illinois at Urbana‐ChampaignInstitute of AviationSavoy, IL 61874


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1a# Type of Error %

1 “Right data, wrong field”

a. Drug/Dose Slip 32%

b. Volume/Concentration 3%

c. Rate / Concentration Slip

4%

2 Decimal Point Error 10%

3 Wrong Unit (“mL” vs “mg”) 7%

4 Manipulation Bolus 14%

5 Mis‐programming 23%

6 Other Use Error 7%

1b1c

234

5

6

PCA – 3 Yr. SummaryWhat (Outcome)

Injury 112

Death 16

When (Phase)

Unknown 60

Programming Pump 44

Change 10

Global 19

Infusion Running 5

Where

‐‐‐

How (Hazardous Situation)

Unknown 30

Over infusion 91

Free Flow 6

Other 1

Why (Cause )

Wrong Field 27 ‐ 49

Decimal Point Error 7 ‐ 13

Wrong units selected 5 ‐ 9

Manipulation Bolus 10 ‐ 18

Mis‐programming 16 ‐ 29

Other Use Error 5 ‐ 10 33

PCA Additional Information

After the Adverse Event…

49 of 128 Device Log Examined (38%)

28 of 128 Devices Evaluated (22%)

When Use Error was a Cause..

5 of 67 were not caught by Second Clinician Verification (7%)

11 of 67 continued despite a Limits Warning (16%)

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Elastomeric MAUDE Data Review


Product Code = MEBDeath & Injury Reports



Death &Possible Death

2%

Injury98%

Elastomeric – What happened?

36


Elastomeric – When did it happen?

37

Unknown62%

Teardown 14%

Global 9%

InfusionRunning14%

Other 1%

Over Infusion 5% Unknown 5% Other 4% Under Infusion 3% Interruption 1% Chemical Exp 1%Allergic Reaction 1%

BodilyInjury56%

ForeignObject14%

Infection9%

Elastomeric – How did it happen?

38

Joint / Chondrolysis

53%

Catheter Damage 14%

Elastomeric – Why did it happen?

39

Use Error 2% Leak 2%Other 5%Unknown 24%

Elastomeric – 3 Yr. SummaryWhat (Outcome)

Injury 185

Death 4

When (Phase)

Unknown 118

Tear Down 27

Infusion Running 26

Global 17

Setup 1

Where

‐‐‐


Bodily Injury 105

Foreign Object 27

Infection 17

Over Infusion 10

Other 30

Why (Cause)

Joint / Chondrolysis 101 ‐ 133

Catheter Damage 26 ‐ 34

Leak 4 ‐ 5

40

Enteral MAUDE Data Review


Product Code = LZHDeath & Injury Reports



Harm when using an Enteral pump?

42

EVENT DESCRIPTIONIt was reported to [redacted] that a customer had an issue with a feeding pump. The customer reported that the pump was set at 35ml/hr and the feeding bag was full (at 500ml). At 6am the next morning, she found her daughter unresponsive/deceased and the bag completely empty.

Enteral – What happened?

43

Death &Possible Death

8%

Injury 92%Denominator: 40 Adverse Events

Enteral – When did it happen?

44

Unknown37%

ManageExceptions

35% InfusionRunning15%

Global5%

Programming Pump8%

Interruption22%

Over Infusion17%

Under Infusion18%

Gastric AirDelivery17%

Other 5%

Exposure toElectrical Energy 3%Burn/Fire/Smoke

3%

Unknown 17%

Enteral – How did it happen?

45

Unknown 47%

Failed toAlarm33%

Use Error 10%

Other 10%

Enteral – Why did it happen?

46

Enteral – 3 Yr. SummaryWhat (Outcome)

Injury 37

Death 3

When (Phase)

Unknown 15

Manage Exceptions 14

Infusion Running 6

Programming Pump 3

Global 2

Where

‐‐‐


Unknown 7

Interruption 9

Over Infusion 7

Under Infusion 7

Gastric Air Delivery 6

Other 4

Why (Cause)

Failed to Alarm 13 ‐ 25

Use Error 4 ‐ 8

Other 4 ‐ 8

47

Enteral – Additional Information

After the Adverse Events, 9 of 40 devices were evaluated (23%)

12 of 40 events were reported as being on a child (30%)

48

General Purpose (FRN) MAUDE Data Review

Report Dates 1/1/2007 – 12/31/2009 Subset

Event Dates 1/1/2007 – 12/31/2009 Subset

Product Code = FRN

Death & Injury Reports


600 D&I Reports / 347 Reviewed / 238 Events Meet Criteria

Death &PossibleDeath24%

Injury76%

FRN – What happened?

50


Programming21%

Unknown25%

InfusionRunning41%

FRN – When did it happen?

Change 6%Setup 3%Global 1%Deployment 1%Hand‐off 1%Tear Down 1%

51

Interruption29%

OverInfusion50%

Under Infusion 4%

Unknown 3%

Exposure toElectrical Energy 1%

FreeFlow12%

Delay 1%

FRN – How did it happen?

52

Use Error33%

Unknown27%

Other 1%Physical Damage 6%

Failed to Alarm 5%

Failure/Malfunction

22%

Alarm 3%

Secondary Use Error 3%FRN – Why did it happen?

53

Misprogramming53%

Decimal PointError 30%

Wrong UnitsSelected 7%

Drug/DoseSlip 7%

Rate/ConcentrationSlip 3%


54

General Purpose – 3 Yr. SummaryWhat (Outcome)

Injury 181

Death 57

When (Phase)

Unknown 60

Infusion Running 98

Programming Pump 50

Change 14

Setup 7

Other 9


Unknown 8

Over Infusion 118

Under Infusion 10

Interruption 70

Free Flow 28

Why (Cause)

Use Error 79 ‐ 109

Secondary Use Error 7 ‐ 10

Alarm 8 ‐ 11

Failure / Malfunction 51 ‐ 70

Failed to Alarm 12 ‐ 17

Physical Damage 14 ‐ 19 55

General Purpose – Addt’l Information

After the Adverse Event…63 of 238 Device Log Examined (26%)77 of 238 Devices Evaluated (32%)

Breakdown of device typeLVP 187Ambulatory 26Syringe Pump 26

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• Methodology



• Recall Review

• Results Summary

• Open Discussion

57

Recall Review

Timeframe: 1/1/2005 through 9/30/2010

Infusion pumps excluding Insulin

Class I Recalls

All manufacturers / all brands

12 Recalls / 21 Issues

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Class I Recall Review

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Issue Count % Failure Leads to Interruption 8 38% Use Related Error 5 24%Failure Leads to Other Hazard 4 19%Fail to Alarm 2 10%False Alarm 1 5% Other 1 5%Total 21 100%


• Methodology



• Recall Review

• Results Summary

• Open Discussion

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Elastomeric ‐ Harm per year

Joint / Chondrolysis 33.7 ‐ 44.3Catheter Damage 8.7 ‐ 11.3Leak 1.3 ‐ 1.7Use Error 1 ‐ 1.3

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PCA (42.6)

Enteral (13.3)

FRN (79.3)

Total (135.3)

Failure / Malfunction 17 ‐ 23.3 17 ‐ 23.3 Use: Mis‐programming 5.3 ‐ 9.7 10.3 ‐ 10.3 15.6 ‐ 20Use: Drug / Dose Slip 7.3 ‐ 13.3 1.3 ‐ 1.3 8.6 ‐ 14.6Use: Decimal Point Error 2.3 ‐ 4.3 6 ‐ 6 8.3 ‐ 10.3Failed to Alarm 4.3 ‐ 8.3 4 ‐ 5.7 8.3 ‐ 14Physical Damage 4.7 ‐ 6.3 4.7 ‐ 6.3Use: Manipulation 3.3 ‐ 6 3.3 ‐ 6Use: Wrong units 1.7 ‐ 3 1.3 ‐ 1.3 3 ‐ 4.3Use: Other 1.7 ‐ 3 1.3 ‐ 2.7 3 ‐ 5.7Alarm 2.7 ‐ 3.7 2.7 ‐ 3.7Use: Secondary 2.3 ‐ 3.3 2.3 ‐ 3.3Use: Rate / Conc. Slip 1 ‐ 1.7 0.7 ‐ 0.7 1.7 ‐ 2.4Use: Volume / Conc. Slip 0.7 ‐ 1.3 0.7 ‐ 1.3Total 23.3 ‐ 42.3 5.7 ‐ 11 50.3 ‐ 62 79.2 ‐ 115.2

Harm per year

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• Methodology



• Recall Review

• Results Summary

• Open Discussion

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Incident Data: Filling the Gaps, Identifying the Value...

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