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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
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ADS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUMMIT MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 381 381
2015 99 99
2016 56 56
2017 43 43
2018 256 256
2019 131 131
2020 2331 2331
2021 3775 3775
2022 6443 6443
2023 3984 3984
2024 738 738

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5977 5977
Crack 4449 4449
Corroded 3889 3889
Device Markings/Labelling Problem 3869 3869
Failure to Align 2482 2482
Contamination 1630 1630
Appropriate Term/Code Not Available 987 987
Device Alarm System 943 943
Deformation Due to Compressive Stress 848 848
Physical Resistance/Sticking 784 784
No Apparent Adverse Event 721 721
Naturally Worn 664 664
Inaccurate Delivery 610 610
Failure to Calibrate 600 600
Device Sensing Problem 570 570
Display Difficult to Read 563 563
Computer Software Problem 517 517
Circuit Failure 382 382
Excess Flow or Over-Infusion 363 363
Misassembled 353 353
Insufficient Information 275 275
Calibration Problem 249 249
Application Program Freezes, Becomes Nonfunctional 245 245
Degraded 240 240
Insufficient Flow or Under Infusion 224 224
Volume Accuracy Problem 206 206
Infusion or Flow Problem 179 179
Failure to Analyze Signal 178 178
Communication or Transmission Problem 150 150
Display or Visual Feedback Problem 150 150
Failure to Read Input Signal 117 117
Device Displays Incorrect Message 112 112
Failure to Sense 94 94
Failure to Deliver 92 92
Device Inoperable 76 76
Occlusion Within Device 70 70
Fluid/Blood Leak 58 58
Use of Device Problem 53 53
Obstruction of Flow 50 50
No Audible Alarm 49 49
Electrical /Electronic Property Problem 47 47
Mechanical Problem 45 45
Loss of Power 45 45
Air/Gas in Device 45 45
Audible Prompt/Feedback Problem 44 44
Output Problem 42 42
Component Misassembled 42 42
Inaccurate Flow Rate 42 42
Improper Flow or Infusion 39 39
Battery Problem 38 38
Connection Problem 36 36
Pumping Stopped 36 36
Material Integrity Problem 30 30
Leak/Splash 28 28
No Display/Image 28 28
Application Program Problem 27 27
False Alarm 26 26
Failure to Power Up 26 26
Peeled/Delaminated 25 25
Adverse Event Without Identified Device or Use Problem 25 25
Fail-Safe Problem 25 25
Failure to Infuse 21 21
Component Missing 21 21
Missing Information 19 19
Defective Alarm 18 18
Contamination /Decontamination Problem 17 17
Loose or Intermittent Connection 16 16
Mechanics Altered 15 15
Device Operates Differently Than Expected 14 14
Defective Component 14 14
Product Quality Problem 13 13
Power Problem 13 13
No Flow 12 12
Improper or Incorrect Procedure or Method 12 12
Device Misassembled During Manufacturing /Shipping 12 12
Increase in Pressure 10 10
Complete Blockage 10 10
Failure to Cycle 10 10
Application Program Problem: Medication Error 10 10
Pressure Problem 10 10
Device Difficult to Maintain 9 9
Partial Blockage 9 9
Thermal Decomposition of Device 9 9
Incorrect Measurement 8 8
Nonstandard Device 8 8
Device Slipped 8 8
Detachment of Device or Device Component 8 8
Loss of Data 8 8
Defective Device 8 8
Blocked Connection 8 8
Pumping Problem 8 8
Programming Issue 7 7
Application Program Version or Upgrade Problem 7 7
Failure to Pump 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Failure to Charge 7 7
Smoking 6 6
Noise, Audible 6 6
Intermittent Loss of Power 6 6
Inaccurate Information 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13027 13027
No Patient Involvement 3695 3695
Insufficient Information 967 967
No Consequences Or Impact To Patient 337 339
No Known Impact Or Consequence To Patient 272 272
No Information 175 175
Pain 33 33
Overdose 24 24
Death 20 20
Not Applicable 13 13
Oversedation 9 9
Inadequate Pain Relief 7 7
Low Oxygen Saturation 6 6
Decreased Respiratory Rate 6 6
Cardiac Arrest 6 6
Fall 6 6
Low Blood Pressure/ Hypotension 6 6
Dizziness 5 5
Underdose 5 5
Numbness 4 4
Cardiopulmonary Arrest 4 4
Hypoglycemia 4 4
Nausea 4 4
High Blood Pressure/ Hypertension 3 3
Bradycardia 3 3
Loss of consciousness 3 3
Lethargy 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Syncope/Fainting 2 2
Diaphoresis 2 2
Coma 2 2
Anxiety 2 2
Dyspnea 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Brain Injury 2 2
Tachycardia 2 2
Under no medication 1 1
Blurred Vision 1 1
Vomiting 1 1
Convulsion, Clonic 1 1
Therapeutic Response, Increased 1 1
Shock 1 1
Overmedicated 1 1
Neurological Deficit/Dysfunction 1 1
Ischemia 1 1
Muscle Weakness 1 1
Fatigue 1 1
Fever 1 1
Gastritis 1 1
Chest Pain 1 1
Bruise/Contusion 1 1
Aneurysm 1 1
Apnea 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Hypoesthesia 1 1
Extubate 1 1
Increased Respiratory Rate 1 1
Chest Tightness/Pressure 1 1
Pallor 1 1
Paresthesia 1 1
Pulmonary Hypertension 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Missed Dose 1 1
Treatment with medication(s) 1 1
Hospitalization required 1 1
Decreased Sensitivity 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical Inc II Mar-22-2022
2 Baxter Healthcare Corp. II Apr-27-2015
3 CareFusion 303, Inc. II Jan-08-2018
4 Hospira Inc. II Sep-22-2016
5 Hospira Inc. II Jul-08-2016
6 Hospira Inc. II Apr-23-2015
7 Hospira, Inc. II Sep-10-2012
8 Smiths Medical ASD Inc. II Feb-01-2018
9 Smiths Medical ASD, Inc. II Mar-10-2017
10 Smiths Medical ASD, Inc. II Jun-18-2015
11 Smiths Medical ASD, Inc. II Nov-01-2014
12 Smiths Medical ASD, Inc. II Oct-04-2011
13 Smiths Medical ASD, Inc. II Feb-03-2011
14 Smiths Medical ASD, Inc. II Mar-11-2010
15 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
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