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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 258 258
2019 131 131
2020 2331 2331
2021 3774 3774
2022 5715 5715

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4205 4205
Crack 3809 3809
Device Markings/Labelling Problem 3111 3111
Corroded 2740 2740
Failure to Align 1752 1752
Contamination 1262 1262
Appropriate Term/Code Not Available 980 980
Deformation Due to Compressive Stress 846 846
No Apparent Adverse Event 584 584
Naturally Worn 523 523
Computer Software Problem 508 508
Device Sensing Problem 450 450
Physical Resistance/Sticking 447 447
Inaccurate Delivery 386 386
Display Difficult to Read 376 376
Failure to Calibrate 359 359
Misassembled 347 347
Circuit Failure 250 250
Degraded 240 240
Application Program Freezes, Becomes Nonfunctional 239 239
Excess Flow or Over-Infusion 232 232
Device Alarm System 199 199
Insufficient Information 199 199
Calibration Problem 182 182
Failure to Analyze Signal 155 155
Infusion or Flow Problem 149 149
Display or Visual Feedback Problem 134 134
Insufficient Flow or Under Infusion 124 124
Communication or Transmission Problem 123 123
Failure to Read Input Signal 108 108
Volume Accuracy Problem 103 103
Device Displays Incorrect Message 65 65
Audible Prompt/Feedback Problem 42 42
Electrical /Electronic Property Problem 40 40
Component Misassembled 28 28
Pumping Stopped 27 27
Failure to Power Up 24 24
Application Program Problem 24 24
Use of Device Problem 23 23
Improper Flow or Infusion 22 22
Peeled/Delaminated 22 22
No Display/Image 22 22
Output Problem 21 21
Missing Information 18 18
Inaccurate Flow Rate 18 18
Connection Problem 16 16
Battery Problem 16 16
Contamination /Decontamination Problem 15 15
Failure to Infuse 15 15
Obstruction of Flow 15 15
Fluid/Blood Leak 13 13
Mechanics Altered 13 13
Loose or Intermittent Connection 11 11
Fail-Safe Problem 11 11
Failure to Deliver 10 10
Improper or Incorrect Procedure or Method 10 10
Mechanical Problem 10 10
Failure to Cycle 10 10
False Alarm 10 10
Component Missing 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Device Slipped 8 8
Protective Measures Problem 8 8
Pumping Problem 7 7
Pressure Problem 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Detachment of Device or Device Component 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Application Program Version or Upgrade Problem 6 6
Leak/Splash 6 6
Incorrect Measurement 6 6
Nonstandard Device 6 6
Occlusion Within Device 5 5
Loss of Power 5 5
Increase in Pressure 5 5
Failure to Prime 5 5
Defective Component 5 5
Device Operates Differently Than Expected 5 5
Application Program Problem: Medication Error 5 5
Air/Gas in Device 5 5
Complete Loss of Power 4 4
Noise, Audible 4 4
No Flow 4 4
Device Contamination with Chemical or Other Material 4 4
Lack of Maintenance Documentation or Guidelines 4 4
Material Integrity Problem 4 4
No Audible Prompt/Feedback 4 4
Defective Alarm 4 4
No Audible Alarm 4 4
Material Discolored 4 4
Failure to Charge 3 3
Smoking 3 3
Defective Device 3 3
Charging Problem 3 3
Computer System Security Problem 3 3
Priming Problem 3 3
Inaccurate Information 3 3
Activation Problem 2 2
Intermittent Communication Failure 2 2
Unexpected Shutdown 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8295 8295
No Patient Involvement 3478 3478
No Consequences Or Impact To Patient 196 197
No Known Impact Or Consequence To Patient 180 180
Insufficient Information 168 168
No Information 164 164
Not Applicable 13 13
Pain 9 9
Overdose 8 8
Death 5 5
Low Oxygen Saturation 5 5
Underdose 4 4
Low Blood Pressure/ Hypotension 4 4
Dizziness 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Inadequate Pain Relief 3 3
Decreased Respiratory Rate 2 2
Coma 2 2
Hypoxia 2 2
Cardiac Arrest 2 2
High Blood Pressure/ Hypertension 2 2
Oversedation 2 2
Nausea 2 2
Respiratory Distress 2 2
No Code Available 2 2
Syncope/Fainting 1 1
Paresthesia 1 1
Respiratory Insufficiency 1 1
Blurred Vision 1 1
Vomiting 1 1
Neurological Deficit/Dysfunction 1 1
Muscle Weakness 1 1
Dyspnea 1 1
Fatigue 1 1
Bradycardia 1 1
Bruise/Contusion 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
Numbness 1 1
Lethargy 1 1
Patient Problem/Medical Problem 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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