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 Code	DWJ
Regulation Number	870.5900
Device Class	2

Premarket Reviews
Manufacturer	Decision
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
HADLEIGH HEALTH TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
IOB MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	3
MEDIVANCE, INC.
	SUBSTANTIALLY EQUIVALENT	3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Cooling	2621	2622
Failure to Pump	2247	2247
Defective Component	2164	2164
Device Sensing Problem	2161	2162
Inaccurate Flow Rate	1785	1785
Gas/Air Leak	1463	1463
Insufficient Heating	1428	1428
Restricted Flow rate	1118	1118
Decreased Pump Speed	1012	1012
Circuit Failure	755	755
Pumping Problem	620	620
Failure to Calibrate	522	522
Temperature Problem	487	489
Computer Operating System Problem	434	434
Operating System Becomes Nonfunctional	355	355
Overheating of Device	334	334
Nonstandard Device	250	250
Device Displays Incorrect Message	240	240
Fluid/Blood Leak	238	238
Material Fragmentation	216	216
Improper or Incorrect Procedure or Method	180	180
Overfill	175	175
Calibration Problem	161	161
Power Problem	153	153
Device Alarm System	146	146
Use of Device Problem	145	145
Therapeutic or Diagnostic Output Failure	119	120
Lack of Effect	116	116
Infusion or Flow Problem	114	114
Adverse Event Without Identified Device or Use Problem	109	109
Deformation Due to Compressive Stress	108	108
Fitting Problem	107	107
Material Split, Cut or Torn	96	96
Patient Device Interaction Problem	90	90
Alarm Not Visible	88	88
Display or Visual Feedback Problem	83	83
Insufficient Information	83	83
Biocompatibility	83	83
Material Separation	79	79
Electrical Shorting	77	77
Device Handling Problem	75	75
Computer Software Problem	74	74
Component Missing	68	68
Failure to Sense	68	68
No Flow	66	66
Misassembly by Users	65	65
Insufficient Flow or Under Infusion	59	59
Fracture	54	54
Filling Problem	52	52
Protective Measures Problem	51	51

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14110	14113
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	1300	1300
No Patient Involvement	935	935
Chills	197	197
Insufficient Information	121	123
No Code Available	106	106
Patient Problem/Medical Problem	88	88
Burn(s)	85	85
Alteration In Body Temperature	77	77
Inadequate Pain Relief	51	51
Convulsion/Seizure	47	47
Skin Discoloration	42	42
Partial thickness (Second Degree) Burn	38	40
Blister	35	35
Skin Tears	30	30
Shaking/Tremors	27	27
Pressure Sores	22	22
Alteration in Body Temperature	20	20
Bradycardia	19	19
Fever	18	18
Skin Inflammation/ Irritation	17	17
Hypothermia	15	15
Full thickness (Third Degree) Burn	13	13
Superficial (First Degree) Burn	13	13
Paralysis	13	13
Discomfort	12	12
Erythema	12	12
No Information	12	12
Unspecified Infection	11	11
Pain	10	10
Low Blood Pressure/ Hypotension	9	9
Sepsis	9	9
Death	8	8
Necrosis	8	8
Seizures	8	8
Therapeutic Effects, Unexpected	7	7
Bacterial Infection	6	6
Tissue Breakdown	6	6
Sedation	5	5
Burn, Thermal	5	5
Rash	5	5
Burning Sensation	5	5
Unspecified Tissue Injury	4	4
Localized Skin Lesion	4	4
Electric Shock	4	4
Emotional Changes	4	4
Skin Irritation	4	4
Tachycardia	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Augustine Temperature Management, LLC	II	Feb-20-2025
2	Augustine Temperature Management, LLC	II	Feb-14-2025
3	Augustine Temperature Management, LLC	II	Jan-10-2025
4	Augustine Temperature Management, LLC	II	Dec-18-2024
5	Belmont Instrument Corporation	II	Oct-31-2022
6	Belmont Instrument LLC	II	Jun-12-2025
7	Care Essentials Pty., Ltd.	II	Mar-03-2020
8	Medivance Inc.	II	Jul-31-2024
9	Medivance Inc.	II	Mar-26-2024