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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 BIOMEDICAL & DESIGN, LLC
  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 3
CINCINNATI SUB-ZERO PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
GALMAZ BIOTECH S.L.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GERATHERM MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INSPIRATION HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 5
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 2
MTRE ADVANCED TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
PINTLER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SMITH MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
THE SURGICAL COMPANY INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
THE SURGICAL COMPANY INTERNATIONAL BV (AS THE 37COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
VITAHEAT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELKINS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 116 116
2015 245 245
2016 1401 1401
2017 1473 1473
2018 1517 1517
2019 2294 2294
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 2230 2232

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3068 3068
Insufficient Cooling 2785 2785
Device Sensing Problem 2264 2264
Inaccurate Flow Rate 1819 1819
Temperature Problem 1801 1801
Failure to Pump 1797 1797
Insufficient Heating 1482 1482
Device Displays Incorrect Message 1478 1478
Gas/Air Leak 1369 1369
Restricted Flow rate 1106 1106
Decreased Pump Speed 886 886
Circuit Failure 768 768
Pumping Problem 660 660
Failure to Calibrate 560 560
Device Operates Differently Than Expected 550 550
Overheating of Device 363 363
Adverse Event Without Identified Device or Use Problem 361 361
Operating System Becomes Nonfunctional 358 358
Computer Operating System Problem 336 336
Microbial Contamination of Device 332 332
Insufficient Flow or Under Infusion 314 314
No Flow 293 293
Fluid/Blood Leak 288 288
Infusion or Flow Problem 266 266
Device Alarm System 262 262
Improper or Incorrect Procedure or Method 262 262
Nonstandard Device 260 260
Product Quality Problem 247 247
Insufficient Information 206 206
Contamination 196 196
Therapeutic or Diagnostic Output Failure 194 194
Display or Visual Feedback Problem 194 194
Material Fragmentation 189 189
Leak/Splash 176 178
Use of Device Problem 160 160
Defective Device 145 145
Filling Problem 145 145
Air Leak 143 143
Overfill 139 139
Protective Measures Problem 135 135
Power Problem 126 126
No Display/Image 113 113
Patient-Device Incompatibility 112 112
Improper Flow or Infusion 112 112
Break 112 112
Calibration Problem 106 106
Fitting Problem 99 99
Lack of Effect 97 97
Computer Software Problem 97 97
Deformation Due to Compressive Stress 89 89

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11070 11072
No Known Impact Or Consequence To Patient 4983 4983
No Consequences Or Impact To Patient 3577 3577
No Patient Involvement 2048 2048
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1215 1215
Alteration In Body Temperature 930 930
Patient Problem/Medical Problem 366 366
Unspecified Infection 364 365
No Information 331 331
No Code Available 222 222
Chills 205 205
Post Operative Wound Infection 167 167
Burn(s) 156 156
Death 156 156
Inadequate Pain Relief 119 119
Insufficient Information 114 114
Injury 114 114
Bacterial Infection 103 104
Partial thickness (Second Degree) Burn 99 99
Shaking/Tremors 84 84
Therapeutic Effects, Unexpected 69 69
Hypothermia 66 66
Skin Discoloration 55 55
Erythema 54 54
Skin Tears 50 50
Convulsion/Seizure 45 45
Burn, Thermal 44 44
Fever 43 43
Superficial (First Degree) Burn 43 43
Cardiac Arrest 37 37
Ambulation Difficulties 37 37
Seizures 35 35
Pain 35 35
Swelling 32 32
Full thickness (Third Degree) Burn 30 30
Tissue Damage 30 30
Staphylococcus Aureus 28 28
Pressure Sores 28 28
Skin Irritation 25 25
Blister 25 25
Bradycardia 25 25
Rash 24 24
Sepsis 20 20
Discomfort 18 18
Alteration in Body Temperature 17 17
Low Blood Pressure/ Hypotension 17 17
Paralysis 15 15
Therapeutic Response, Decreased 15 15
Limited Mobility Of The Implanted Joint 15 15
Pneumonia 14 14

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-12-2018
2 Arizant Inc II Mar-01-2010
3 Bard Medical Division II Apr-27-2019
4 Bard Medical Division II Jul-24-2018
5 Belmont Instrument Corporation II Oct-31-2022
6 C.R. Bard, Inc. III Feb-12-2018
7 C.R. Bard, Inc. II Dec-20-2017
8 C.R. Bard, Inc. II Aug-16-2017
9 C.R. Bard, Inc. III Aug-05-2016
10 C.R. Bard, Inc. II May-06-2016
11 C.R. Bard, Inc. II Apr-14-2016
12 C.R. Bard, Inc. II Feb-05-2016
13 Care Essentials Pty., Ltd. II Mar-03-2020
14 Cincinnati Sub-Zero Products Inc II Jun-10-2014
15 Cincinnati Sub-Zero Products Inc II Dec-04-2013
16 Cincinnati Sub-Zero Products Inc II Sep-16-2013
17 Cincinnati Sub-Zero Products Inc II May-24-2012
18 Cincinnati Sub-Zero Products Inc II Feb-07-2012
19 Cincinnati Sub-Zero Products Inc II Sep-01-2011
20 Cincinnati Sub-Zero Products Inc II Jul-27-2011
21 Cincinnati Sub-Zero Products Inc II Jul-14-2011
22 Cincinnati Sub-Zero Products Inc II Jul-01-2011
23 Cincinnati Sub-Zero Products Inc II Mar-30-2011
24 Cincinnati Sub-Zero Products Inc II Feb-04-2010
25 Cincinnati Sub-Zero Products Inc II Oct-29-2009
26 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
27 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
28 Kimberly-Clark Corporation II Nov-29-2012
29 Kimberly-Clark Corporation II Aug-09-2012
30 Medivance Inc. II Jul-31-2024
31 Medivance Inc. II Mar-26-2024
32 Medtronic Perfusion Systems II Mar-06-2018
33 Pintler Medical LLC II Apr-12-2019
34 Smiths Medical ASD, Inc. II May-22-2014
35 Stryker Medical Division of Stryker Corporation II Oct-24-2018
36 Stryker Medical Division of Stryker Corporation II Jan-27-2018
37 Stryker Medical Division of Stryker Corporation II May-10-2017
38 Stryker Medical Division of Stryker Corporation II Feb-05-2014
39 Tec Com Gmbh II Nov-12-2019
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