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	2648	2649
Failure to Pump	2277	2277
Device Sensing Problem	2178	2184
Defective Component	2165	2165
Inaccurate Flow Rate	1799	1799
Gas/Air Leak	1467	1467
Insufficient Heating	1439	1440
Restricted Flow rate	1131	1131
Decreased Pump Speed	1015	1015
Circuit Failure	760	760
Pumping Problem	625	625
Failure to Calibrate	522	522
Temperature Problem	487	489
Computer Operating System Problem	443	443
Operating System Becomes Nonfunctional	355	355
Overheating of Device	336	336
Nonstandard Device	278	278
Fluid/Blood Leak	241	241
Device Displays Incorrect Message	240	240
Material Fragmentation	216	216
Improper or Incorrect Procedure or Method	180	180
Overfill	175	176
Calibration Problem	166	166
Power Problem	154	154
Use of Device Problem	148	148
Device Alarm System	146	146
Therapeutic or Diagnostic Output Failure	119	120
Lack of Effect	117	117
Infusion or Flow Problem	114	114
Deformation Due to Compressive Stress	110	110
Adverse Event Without Identified Device or Use Problem	109	110
Fitting Problem	109	110
Material Split, Cut or Torn	99	99
Patient Device Interaction Problem	91	91
Alarm Not Visible	88	88
Insufficient Information	84	84
Display or Visual Feedback Problem	83	84
Biocompatibility	83	83
Material Separation	80	80
Electrical Shorting	77	77
Device Handling Problem	76	76
Computer Software Problem	75	75
Component Missing	69	69
Failure to Sense	69	70
No Flow	66	66
Misassembly by Users	66	66
Insufficient Flow or Under Infusion	59	59
Fracture	55	55
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	14248	14262
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	1303	1304
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	43	43
Partial thickness (Second Degree) Burn	38	40
Blister	35	35
Skin Tears	31	31
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
No Information	12	12
Erythema	12	13
Discomfort	12	12
Unspecified Infection	11	11
Pain	10	10
Sepsis	9	9
Low Blood Pressure/ Hypotension	9	9
Seizures	8	8
Necrosis	8	8
Death	8	8
Therapeutic Effects, Unexpected	7	7
Bacterial Infection	6	6
Tissue Breakdown	6	6
Sedation	5	5
Burn, Thermal	5	5
Burning Sensation	5	5
Rash	5	6
Emotional Changes	4	4
Unspecified Tissue Injury	4	4
Skin Irritation	4	4
Electric Shock	4	4
Localized Skin Lesion	4	4
Swelling/ Edema	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