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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
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 3
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BCG MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRAIN COOL AB
  SUBSTANTIALLY EQUIVALENT 1
BRAINCOOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 5
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
THE SURGICAL COMPANY INTERNATIONAL BV (AS THE 37COMPANY)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1473 1473
2018 1517 1517
2019 2294 2294
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 2869 2871

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3118 3118
Insufficient Cooling 2826 2826
Device Sensing Problem 2334 2334
Failure to Pump 1845 1845
Inaccurate Flow Rate 1830 1830
Temperature Problem 1674 1674
Insufficient Heating 1521 1521
Gas/Air Leak 1418 1418
Device Displays Incorrect Message 1198 1198
Restricted Flow rate 1155 1155
Decreased Pump Speed 910 910
Circuit Failure 790 790
Pumping Problem 666 666
Failure to Calibrate 560 560
Device Operates Differently Than Expected 390 390
Computer Operating System Problem 370 370
Operating System Becomes Nonfunctional 358 358
Overheating of Device 354 354
Adverse Event Without Identified Device or Use Problem 287 287
Fluid/Blood Leak 275 275
Device Alarm System 257 257
No Flow 256 256
Improper or Incorrect Procedure or Method 245 245
Nonstandard Device 235 235
Infusion or Flow Problem 223 223
Material Fragmentation 195 195
Display or Visual Feedback Problem 194 194
Insufficient Flow or Under Infusion 189 189
Therapeutic or Diagnostic Output Failure 186 186
Use of Device Problem 150 150
Defective Device 145 145
Overfill 145 145
Filling Problem 136 136
Calibration Problem 134 134
Protective Measures Problem 134 134
Insufficient Information 133 133
Power Problem 132 132
Leak/Splash 125 127
Break 109 109
No Display/Image 108 108
Patient-Device Incompatibility 106 106
Fitting Problem 103 103
Lack of Effect 102 102
Computer Software Problem 98 98
Deformation Due to Compressive Stress 94 94
Material Split, Cut or Torn 89 89
Incorrect, Inadequate or Imprecise Result or Readings 85 85
Appropriate Term/Code Not Available 84 84
Biocompatibility 82 82
Air Leak 80 80

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11681 11683
No Known Impact Or Consequence To Patient 4370 4370
No Consequences Or Impact To Patient 3421 3421
No Patient Involvement 2018 2018
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1239 1239
Alteration In Body Temperature 862 862
Patient Problem/Medical Problem 366 366
No Information 236 236
Chills 208 208
No Code Available 174 174
Inadequate Pain Relief 117 117
Insufficient Information 114 114
Burn(s) 107 107
Death 89 89
Shaking/Tremors 81 81
Bacterial Infection 63 63
Partial thickness (Second Degree) Burn 57 57
Hypothermia 54 54
Skin Discoloration 49 49
Convulsion/Seizure 46 46
Therapeutic Effects, Unexpected 44 44
Fever 39 39
Erythema 38 38
Skin Tears 37 37
Burn, Thermal 35 35
Seizures 34 34
Unspecified Infection 30 30
Pressure Sores 27 27
Injury 26 26
Bradycardia 25 25
Superficial (First Degree) Burn 25 25
Blister 25 25
Skin Irritation 19 19
Post Operative Wound Infection 19 19
Tissue Damage 19 19
Full thickness (Third Degree) Burn 19 19
Rash 17 17
Cardiac Arrest 17 17
Alteration in Body Temperature 17 17
Low Blood Pressure/ Hypotension 17 17
Discomfort 17 17
Paralysis 15 15
Swelling 15 15
Skin Inflammation/ Irritation 14 14
Sepsis 14 14
Pneumonia 12 12
Necrosis 11 11
Hyperthermia 11 11
Not Applicable 9 9
Burning Sensation 8 8

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-12-2018
2 Bard Medical Division II Apr-27-2019
3 Bard Medical Division II Jul-24-2018
4 Belmont Instrument Corporation II Oct-31-2022
5 C.R. Bard, Inc. III Feb-12-2018
6 C.R. Bard, Inc. II Dec-20-2017
7 C.R. Bard, Inc. II Aug-16-2017
8 Care Essentials Pty., Ltd. II Mar-03-2020
9 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
10 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
11 Medivance Inc. II Jul-31-2024
12 Medivance Inc. II Mar-26-2024
13 Medtronic Perfusion Systems II Mar-06-2018
14 Pintler Medical LLC II Apr-12-2019
15 Stryker Medical Division of Stryker Corporation II Oct-24-2018
16 Stryker Medical Division of Stryker Corporation II Jan-27-2018
17 Stryker Medical Division of Stryker Corporation II May-10-2017
18 Tec Com Gmbh II Nov-12-2019
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