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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 2
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRAIN COOL 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
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 1

MDR Year MDR Reports MDR Events
2018 1517 1517
2019 2294 2294
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 2287 2287

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2602 2602
Insufficient Cooling 2152 2152
Device Sensing Problem 1859 1859
Inaccurate Flow Rate 1342 1342
Temperature Problem 1341 1341
Failure to Pump 1308 1308
Insufficient Heating 1124 1124
Gas/Air Leak 1032 1032
Restricted Flow rate 858 858
Device Displays Incorrect Message 777 777
Decreased Pump Speed 660 660
Circuit Failure 599 599
Pumping Problem 492 492
Failure to Calibrate 425 425
Operating System Becomes Nonfunctional 289 289
Overheating of Device 280 280
Computer Operating System Problem 271 271
Adverse Event Without Identified Device or Use Problem 234 234
Device Alarm System 221 221
Nonstandard Device 220 220
No Flow 201 201
Fluid/Blood Leak 197 197
Display or Visual Feedback Problem 188 188
Infusion or Flow Problem 186 186
Therapeutic or Diagnostic Output Failure 185 185
Improper or Incorrect Procedure or Method 151 151
Device Operates Differently Than Expected 141 141
Defective Device 140 140
Protective Measures Problem 134 134
Insufficient Flow or Under Infusion 120 120
Material Fragmentation 119 119
Use of Device Problem 114 114
Filling Problem 110 110
Power Problem 100 100
Patient-Device Incompatibility 98 98
Insufficient Information 94 94
Break 93 93
Leak/Splash 88 88
No Display/Image 86 86
Computer Software Problem 85 85
Overfill 84 84
Biocompatibility 80 80
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Component Missing 71 71
Appropriate Term/Code Not Available 70 70
Deformation Due to Compressive Stress 68 68
Fitting Problem 68 68
Material Split, Cut or Torn 66 66
Electrical Shorting 57 57
Noise, Audible 55 55
Output Problem 52 52
Improper Flow or Infusion 49 49
Misassembly by Users 49 49
Calibration Problem 46 46
Device Handling Problem 43 43
Material Twisted/Bent 41 41
Failure to Sense 41 41
Excessive Heating 40 40
Patient Device Interaction Problem 38 38
Loss of Power 38 38
Material Separation 36 36
Erratic or Intermittent Display 35 35
Device Dislodged or Dislocated 35 35
Alarm Not Visible 33 33
Fracture 33 33
Failure to Power Up 31 31
Pressure Problem 31 31
Excessive Cooling 27 27
Physical Resistance/Sticking 27 27
Air Leak 27 27
Output below Specifications 26 26
Partial Blockage 25 25
Device Emits Odor 24 24
Electrical /Electronic Property Problem 22 22
Component Misassembled 22 22
Device Inoperable 21 21
Naturally Worn 20 20
Loss of or Failure to Bond 19 19
Unable to Obtain Readings 18 18
Short Fill 17 17
Solder Joint Fracture 17 17
Thermal Decomposition of Device 17 17
Contamination /Decontamination Problem 17 17
Failure of Device to Self-Test 16 16
Suction Problem 15 15
Disconnection 14 14
Loose or Intermittent Connection 14 14
Mechanical Problem 14 14
No Apparent Adverse Event 14 14
Unexpected Shutdown 14 14
Intermittent Loss of Power 13 13
Inadequate Instructions for Healthcare Professional 13 13
Product Quality Problem 12 12
Image Display Error/Artifact 11 11
Crack 11 11
Material Protrusion/Extrusion 11 11
Device Contamination with Chemical or Other Material 10 10
Use of Incorrect Control/Treatment Settings 10 10
Melted 10 10
Inadequate or Insufficient Training 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7964 7964
No Known Impact Or Consequence To Patient 3684 3684
No Consequences Or Impact To Patient 3305 3305
No Patient Involvement 1961 1961
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 932 932
Alteration In Body Temperature 627 627
Patient Problem/Medical Problem 358 358
Chills 162 162
No Code Available 148 148
No Information 108 108
Inadequate Pain Relief 106 106
Insufficient Information 99 99
Burn(s) 76 76
Shaking/Tremors 72 72
Death 48 48
Hypothermia 43 43
Partial thickness (Second Degree) Burn 41 41
Convulsion/Seizure 36 36
Skin Discoloration 33 33
Seizures 29 29
Fever 28 28
Therapeutic Effects, Unexpected 25 25
Burn, Thermal 25 25
Skin Tears 22 22
Blister 22 22
Pressure Sores 21 21
Unspecified Infection 20 20
Erythema 18 18
Bradycardia 18 18
Discomfort 17 17
Injury 15 15
Alteration in Body Temperature 15 15
Full thickness (Third Degree) Burn 14 14
Paralysis 14 14
Rash 13 13
Skin Irritation 13 13
Low Blood Pressure/ Hypotension 13 13
Superficial (First Degree) Burn 13 13
Skin Inflammation/ Irritation 12 12
Cardiac Arrest 12 12
Sepsis 11 11
Pneumonia 10 10
Bacterial Infection 9 9
Necrosis 7 7
Swelling 7 7
Tissue Damage 7 7
Pain 6 6
Hyperthermia 6 6
Burning Sensation 5 5
Sedation 5 5
Therapeutic Response, Decreased 5 5
Respiratory Failure 5 5
Complaint, Ill-Defined 4 4
Twitching 4 4
Pulmonary Edema 4 4
Respiratory Distress 4 4
High Blood Pressure/ Hypertension 4 4
Hypoxia 4 4
Bruise/Contusion 4 4
Abrasion 3 3
Cardiopulmonary Arrest 3 3
Emotional Changes 3 3
Brain Injury 3 3
Skin Inflammation 3 3
Electric Shock 3 3
Chemical Exposure 2 2
Confusion/ Disorientation 2 2
Tissue Breakdown 2 2
Sweating 2 2
Cardiogenic Shock 2 2
Meningitis 2 2
Unspecified Tissue Injury 2 2
Not Applicable 2 2
Exposure to Body Fluids 2 2
Irritation 2 2
Hemorrhage/Bleeding 2 2
Local Reaction 2 2
Peeling 2 2
Myocardial Infarction 2 2
Scar Tissue 2 2
Urinary Tract Infection 2 2
Tachycardia 2 2
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Heart Failure 1 1
Seizures, Grand-Mal 1 1
Thrombosis 1 1
Overdose 1 1
Respiratory Distress Syndrome of Newborns 1 1
Staphylococcus Aureus 1 1
Septic Shock 1 1
Shock 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hematoma 1 1
Hypovolemic Shock 1 1
Ischemia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Inflammation 1 1

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 Care Essentials Pty., Ltd. II Mar-03-2020
7 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
8 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
9 Medtronic Perfusion Systems II Mar-06-2018
10 Pintler Medical LLC II Apr-12-2019
11 Stryker Medical Division of Stryker Corporation II Oct-24-2018
12 Stryker Medical Division of Stryker Corporation II Jan-27-2018
13 Tec Com Gmbh II Nov-12-2019
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