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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, pca
Product CodeMEA
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITHS MEDICAL ADS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 257 257
2019 130 130
2020 2331 2331
2021 3774 3774
2022 3779 3779

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3570 3570
Crack 3479 3479
Device Markings/Labelling Problem 2725 2725
Corroded 2239 2239
Failure to Align 1528 1528
Contamination 1056 1056
Appropriate Term/Code Not Available 980 980
Deformation Due to Compressive Stress 845 845
No Apparent Adverse Event 542 542
Naturally Worn 500 500
Computer Software Problem 498 498
Device Sensing Problem 415 415
Misassembled 343 343
Physical Resistance/Sticking 324 324
Inaccurate Delivery 278 278
Display Difficult to Read 275 275
Failure to Calibrate 271 271
Degraded 240 240
Application Program Freezes, Becomes Nonfunctional 236 236
Circuit Failure 218 218
Excess Flow or Over-Infusion 216 216
Insufficient Information 166 166
Failure to Analyze Signal 148 148
Infusion or Flow Problem 147 147
Calibration Problem 135 135
Display or Visual Feedback Problem 133 133
Device Alarm System 124 124
Insufficient Flow or Under Infusion 108 108
Failure to Read Input Signal 105 105
Communication or Transmission Problem 102 102
Volume Accuracy Problem 85 85
Device Displays Incorrect Message 65 65
Audible Prompt/Feedback Problem 37 37
Electrical /Electronic Property Problem 32 32
Pumping Stopped 24 24
Failure to Power Up 23 23
Application Program Problem 22 22
Use of Device Problem 18 18
Improper Flow or Infusion 17 17
Inaccurate Flow Rate 17 17
Peeled/Delaminated 16 16
Output Problem 16 16
Missing Information 16 16
Battery Problem 14 14
Mechanics Altered 13 13
Fluid Leak 13 13
No Display/Image 13 13
Contamination /Decontamination Problem 12 12
Failure to Infuse 11 11
Loose or Intermittent Connection 11 11
Improper or Incorrect Procedure or Method 10 10
False Alarm 10 10
Failure to Cycle 10 10
Connection Problem 9 9
Fail-Safe Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Device Slipped 8 8
Pressure Problem 7 7
Component Missing 7 7
Application Program Version or Upgrade Problem 6 6
Incorrect Measurement 6 6
Nonstandard Device 6 6
Occlusion Within Device 5 5
Leak/Splash 5 5
Loss of Power 5 5
Increase in Pressure 5 5
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Failure to Deliver 5 5
Obstruction of Flow 5 5
Detachment of Device or Device Component 5 5
Protective Measures Problem 5 5
Device Operates Differently Than Expected 5 5
Device Contamination with Chemical or Other Material 4 4
No Flow 4 4
Device Misassembled During Manufacturing /Shipping 4 4
No Audible Prompt/Feedback 4 4
Failure to Prime 4 4
Defective Alarm 4 4
Material Discolored 4 4
Complete Loss of Power 4 4
Noise, Audible 4 4
Component Misassembled 4 4
Failure to Charge 3 3
Mechanical Problem 3 3
Smoking 3 3
Computer System Security Problem 3 3
Charging Problem 3 3
Defective Component 3 3
Application Program Problem: Medication Error 3 3
Pumping Problem 3 3
Lack of Maintenance Documentation or Guidelines 3 3
Material Integrity Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Failure of Device to Self-Test 2 2
Inaccurate Dispensing 2 2
Application Security Problem 2 2
Biocompatibility 2 2
Date/Time-Related Software Problem 2 2
Defective Device 2 2
Delivery System Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6368 6368
No Patient Involvement 3478 3478
No Consequences Or Impact To Patient 195 196
No Known Impact Or Consequence To Patient 179 179
No Information 164 164
Insufficient Information 149 149
Not Applicable 13 13
Overdose 8 8
Pain 7 7
Death 5 5
Low Blood Pressure/ Hypotension 4 4
Low Oxygen Saturation 4 4
Underdose 4 4
Dizziness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Inadequate Pain Relief 3 3
Coma 2 2
Decreased Respiratory Rate 2 2
Cardiac Arrest 2 2
High Blood Pressure/ Hypertension 2 2
Respiratory Distress 2 2
Oversedation 2 2
Nausea 2 2
No Code Available 2 2
Syncope/Fainting 1 1
Paresthesia 1 1
Respiratory Insufficiency 1 1
Neurological Deficit/Dysfunction 1 1
Blurred Vision 1 1
Vomiting 1 1
Hypoxia 1 1
Dyspnea 1 1
Fatigue 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Lethargy 1 1
Patient Problem/Medical Problem 1 1
Diaphoresis 1 1
Chest Tightness/Pressure 1 1
Pallor 1 1
Convulsion, Clonic 1 1
Anxiety 1 1
Injury 1 1
Hypoesthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Mar-22-2022
2 CareFusion 303, Inc. II Jan-08-2018
3 Smiths Medical ASD Inc. II Feb-01-2018
4 Smiths Medical ASD, Inc. II Mar-10-2017
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