TPLC - Total Product Life Cycle

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Device	warmer, thermal, infusion fluid
Regulation Description	Infusion pump.
Product Code	LGZ
Regulation Number	880.5725
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARKEY GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
MEQU A/S
	SUBSTANTIALLY EQUIVALENT	2
QUALITY IN FLOW , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMISSON-CARTLEDGE BIOMEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
THE SURGICAL COMPANY INTERNATIONAL B.V.
	SUBSTANTIALLY EQUIVALENT	2
THE SURGICAL COMPANY INTERNATIONAL BV (AS TSC LIFE)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1116	1133
Device Alarm System	374	376
Leak/Splash	312	312
Temperature Problem	281	284
Display or Visual Feedback Problem	209	213
Insufficient Heating	197	200
Break	183	184
Crack	161	161
Defective Alarm	157	159
Overheating of Device	148	149
No Audible Alarm	124	128
Mechanical Problem	117	117
Power Problem	115	115
Failure to Pump	110	113
Fracture	106	107
Defective Component	96	97
Excessive Heating	89	92
Electrical /Electronic Property Problem	83	85
Failure to Power Up	81	82
No Display/Image	79	85
Noise, Audible	79	81
False Alarm	70	72
Pumping Problem	64	65
Connection Problem	57	57
Failure to Calibrate	53	56
Device Sensing Problem	47	48
Key or Button Unresponsive/not Working	45	45
Defective Device	44	44
Circuit Failure	39	39
Detachment of Device or Device Component	37	39
Failure to Sense	37	37
Material Separation	35	35
Audible Prompt/Feedback Problem	32	32
Component Missing	32	32
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Device Damaged Prior to Use	30	31
Patient Device Interaction Problem	30	30
Display Difficult to Read	29	30
Air/Gas in Device	29	32
Failure to Deliver	28	28
Alarm Not Visible	27	27
Calibration Problem	27	28
No Flow	27	27
Insufficient Device Problem Information	23	23
Smoking	21	21
Corroded	21	21
Infusion or Flow Problem	20	20
Contamination	19	19
Improper Flow or Infusion	17	17
No Visual Prompts/Feedback	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3615	3697
Insufficient Information	1247	1265
No Information	98	98
No Patient Involvement	54	54
No Consequences Or Impact To Patient	24	24
Thrombosis/Thrombus	5	5
Urethral Stenosis/Stricture	3	3
Exsanguination	3	3
Ruptured Aneurysm	2	2
Aneurysm	2	2
Ischemia	2	3
Hemorrhage/Blood Loss/Bleeding	2	2
Hypothermia	2	2
Hypovolemia	2	2
Electric Shock	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Death	1	1
Cardiac Arrest	1	1
Adhesion(s)	1	1
Bruise/Contusion	1	1
Pulmonary Embolism	1	1
Partial thickness (Second Degree) Burn	1	1
Hypovolemic Shock	1	1
Loss of consciousness	1	1
Respiratory Arrest	1	1
Obstruction/Occlusion	1	1
Exposure to Body Fluids	1	1
Low Blood Pressure/ Hypotension	1	1
Abrasion	1	1
Skin Inflammation/ Irritation	1	1
No Known Impact Or Consequence To Patient	1	1
Anaphylactoid / Anaphylaxis	1	1
Burn(s)	1	1
Hemothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company	II	Aug-01-2025
2	Belmont Instrument LLC	II	Apr-25-2025
3	Belmont Instrument LLC	II	Apr-25-2025
4	Eight Medical International BV	I	Jul-23-2021
5	RanD S.r.l.	II	Jul-09-2021
6	Smisson-Cartledge Biomedical, LLC	I	Mar-26-2021
7	Smiths Medical ASD Inc.	I	Sep-03-2021