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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, thermal regulating
Regulation Description Thermal regulating system.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeDWJ
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BRAINCOOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 3330 3332
2025 271 271

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 2360 2360
Failure to Pump 1916 1916
Device Sensing Problem 1889 1889
Defective Component 1867 1867
Inaccurate Flow Rate 1509 1509
Gas/Air Leak 1366 1366
Insufficient Heating 1289 1289
Restricted Flow rate 990 990
Decreased Pump Speed 931 931
Circuit Failure 686 686
Pumping Problem 605 605
Failure to Calibrate 522 522
Temperature Problem 476 476
Operating System Becomes Nonfunctional 355 355
Computer Operating System Problem 334 334
Overheating of Device 300 300
Device Displays Incorrect Message 239 239
Nonstandard Device 239 239
Fluid/Blood Leak 207 207
Material Fragmentation 200 200
Improper or Incorrect Procedure or Method 164 164
Overfill 140 140
Device Alarm System 139 139
Power Problem 134 134
Calibration Problem 121 121
Therapeutic or Diagnostic Output Failure 119 119
Infusion or Flow Problem 113 113
Use of Device Problem 110 110
Lack of Effect 105 105
Deformation Due to Compressive Stress 96 96
Fitting Problem 95 95
Adverse Event Without Identified Device or Use Problem 94 94
Material Split, Cut or Torn 84 84
Alarm Not Visible 83 83
Display or Visual Feedback Problem 83 83
Biocompatibility 82 82
Electrical Shorting 74 74
Patient Device Interaction Problem 72 72
Computer Software Problem 70 70
Device Handling Problem 66 66
No Flow 66 66
Component Missing 64 64
Misassembly by Users 63 63
Insufficient Information 63 63
Insufficient Flow or Under Infusion 58 58
Failure to Sense 54 54
Filling Problem 52 52
Protective Measures Problem 51 51
Fracture 50 50
Material Separation 47 47

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12367 12369
No Consequences Or Impact To Patient 1381 1381
No Known Impact Or Consequence To Patient 1380 1380
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1257 1257
No Patient Involvement 935 935
Chills 190 190
Insufficient Information 116 116
No Code Available 106 106
Patient Problem/Medical Problem 88 88
Alteration In Body Temperature 77 77
Burn(s) 63 63
Inadequate Pain Relief 51 51
Convulsion/Seizure 46 46
Skin Discoloration 36 36
Partial thickness (Second Degree) Burn 33 33
Blister 29 29
Skin Tears 29 29
Shaking/Tremors 27 27
Pressure Sores 21 21
Alteration in Body Temperature 18 18
Bradycardia 17 17
Hypothermia 15 15
Skin Inflammation/ Irritation 14 14
Paralysis 13 13
No Information 12 12
Fever 12 12
Superficial (First Degree) Burn 12 12
Full thickness (Third Degree) Burn 11 11
Unspecified Infection 11 11
Erythema 9 9
Low Blood Pressure/ Hypotension 9 9
Seizures 8 8
Death 8 8
Discomfort 8 8
Necrosis 8 8
Sepsis 7 7
Therapeutic Effects, Unexpected 7 7
Burning Sensation 5 5
Rash 5 5
Sedation 5 5
Burn, Thermal 5 5
Unspecified Tissue Injury 4 4
Localized Skin Lesion 4 4
Electric Shock 4 4
Skin Irritation 4 4
Pain 4 4
Injury 3 3
Bacterial Infection 3 3
Bruise/Contusion 3 3
Emotional Changes 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Augustine Temperature Management, LLC II Jan-10-2025
2 Augustine Temperature Management, LLC II Dec-18-2024
3 Belmont Instrument Corporation II Oct-31-2022
4 Care Essentials Pty., Ltd. II Mar-03-2020
5 Medivance Inc. II Jul-31-2024
6 Medivance Inc. II Mar-26-2024
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