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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system/device, pharmacy compounding
Product CodeNEP
Regulation Number 880.5440
Device Class 2

MDR Year MDR Reports MDR Events
2014 7 7
2015 38 38
2016 32 32
2017 27 27
2018 65 66
2019 137 144
2020 80 80
2021 130 130
2022 77 77
2023 91 91
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 154 154
Break 120 126
Leak/Splash 103 103
Mechanical Problem 83 83
Application Program Problem: Dose Calculation Error 50 50
Disconnection 41 41
Output Problem 41 41
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Application Program Problem 32 32
Product Quality Problem 26 26
Inadequate User Interface 24 24
Improper or Incorrect Procedure or Method 20 20
Use of Device Problem 18 18
Failure to Align 18 18
Device Contamination with Chemical or Other Material 15 17
Crack 12 12
Device Operates Differently Than Expected 11 11
Defective Component 11 11
Component Missing 8 8
Contamination 8 8
Excess Flow or Over-Infusion 8 8
Device Displays Incorrect Message 8 8
Improper Flow or Infusion 7 7
Air/Gas in Device 7 7
Contamination of Device Ingredient or Reagent 7 7
Material Separation 6 6
Loose or Intermittent Connection 6 6
Hole In Material 6 6
Unexpected Shutdown 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Application Program Problem: Medication Error 6 6
Material Integrity Problem 6 6
Infusion or Flow Problem 5 5
Material Split, Cut or Torn 5 5
Incorrect Measurement 5 5
Thermal Decomposition of Device 5 5
Microbial Contamination of Device 5 5
Material Puncture/Hole 4 4
Detachment of Device or Device Component 4 4
Device Markings/Labelling Problem 4 4
Difficult to Open or Close 4 4
Precipitate in Device or Device Ingredient 4 4
Occlusion Within Device 4 4
Wireless Communication Problem 4 4
Fail-Safe Problem 4 4
Material Twisted/Bent 3 3
Patient Data Problem 3 3
Device Emits Odor 3 3
Material Opacification 3 3
Device Alarm System 3 3
Degraded 3 3
Expiration Date Error 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Smoking 2 2
Device Dislodged or Dislocated 2 2
Insufficient Flow or Under Infusion 2 2
Inaccurate Delivery 2 2
Tear, Rip or Hole in Device Packaging 2 2
Fracture 2 2
Corroded 2 2
Filling Problem 2 2
Application Program Problem: Parameter Calculation Error 2 2
Labelling, Instructions for Use or Training Problem 2 2
Inaccurate Information 2 2
Data Problem 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Improper Device Output 2 2
Compatibility Problem 1 1
Free or Unrestricted Flow 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unexpected Color 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Melted 1 1
Misassembled 1 1
Nonstandard Device 1 1
Device Difficult to Program or Calibrate 1 1
Unsealed Device Packaging 1 1
Material Fragmentation 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Defective Alarm 1 1
Cut In Material 1 1
Material Rupture 1 1
Short Fill 1 1
Volume Accuracy Problem 1 1
Device Operational Issue 1 1
Delivery System Failure 1 1
Date/Time-Related Software Problem 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
No Known Impact Or Consequence To Patient 165 165
No Patient Involvement 160 167
No Consequences Or Impact To Patient 47 48
Insufficient Information 23 23
No Information 8 8
Hyperglycemia 6 6
Death 3 3
Electrolyte Imbalance 3 3
Not Applicable 2 2
No Code Available 1 1
Dehydration 1 1
Laceration(s) 1 1
Liver Damage/Dysfunction 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Diabetic Ketoacidosis 1 1
Underdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 B Braun Medical, Inc. II Dec-23-2020
2 B. Braun Medical, Inc. II Jul-03-2018
3 Baxa Corporation II Oct-25-2012
4 Baxa Corporation II Apr-09-2012
5 Baxa Corporation II Apr-05-2012
6 Baxter Corporation Englewood II May-18-2015
7 Baxter Corporation Englewood II Jun-22-2014
8 Baxter Corporation Englewood I May-12-2014
9 Baxter Healthcare Corp. II Jan-07-2016
10 Baxter Healthcare Corp. II Dec-29-2013
11 Baxter Healthcare Corp. I Aug-08-2012
12 Baxter Healthcare Corporation I Jul-22-2022
13 HEALTH ROBOTICS S.R.L. II Jan-10-2017
14 ICU Medical, Inc. II Apr-11-2016
15 OmniCell, Inc. II May-22-2023
16 Smiths Medical ASD Inc. II Apr-21-2021
17 The Metrix Company II Jul-22-2016
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