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	1358	1375
Device Alarm System	488	490
Leak/Splash	473	473
Temperature Problem	404	407
Display or Visual Feedback Problem	285	289
Crack	234	234
Break	217	218
Insufficient Heating	211	214
Power Problem	177	177
Defective Alarm	168	170
Overheating of Device	165	166
No Audible Alarm	163	167
Mechanical Problem	161	161
Electrical /Electronic Property Problem	119	121
Failure to Pump	113	116
Defective Component	112	113
Failure to Power Up	111	112
Fracture	111	112
Excessive Heating	103	106
Noise, Audible	94	96
No Display/Image	84	90
False Alarm	82	84
Pumping Problem	76	77
Connection Problem	70	70
Failure to Calibrate	60	63
Device Sensing Problem	59	60
Defective Device	49	49
Infusion or Flow Problem	49	49
Material Separation	46	46
Key or Button Unresponsive/not Working	45	45
Display Difficult to Read	45	46
Circuit Failure	44	44
Failure to Sense	43	43
Pressure Problem	42	42
Detachment of Device or Device Component	39	41
Calibration Problem	38	39
No Flow	35	35
Audible Prompt/Feedback Problem	35	35
Device Damaged Prior to Use	35	36
Component Missing	34	34
Improper Flow or Infusion	32	32
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Air/Gas in Device	30	33
Patient Device Interaction Problem	30	30
Insufficient Device Problem Information	30	30
Failure to Deliver	29	29
Alarm Not Visible	29	29
Output Problem	28	28
Insufficient Flow or Under Infusion	26	26
Smoking	25	25

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3696	3778
Insufficient Information	1254	1272
No Information	661	661
No Patient Involvement	444	444
No Consequences Or Impact To Patient	258	258
No Known Impact Or Consequence To Patient	61	61
Hypovolemic Shock	5	5
Thrombosis/Thrombus	5	5
Death	4	4
Exsanguination	4	4
Patient Problem/Medical Problem	3	3
Urethral Stenosis/Stricture	3	3
Hypothermia	3	3
Electric Shock	2	2
No Code Available	2	2
Ischemia	2	3
Cardiac Arrest	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Aneurysm	2	2
Ruptured Aneurysm	2	2
Loss of consciousness	2	2
Hypovolemia	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Not Applicable	1	1
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Adhesion(s)	1	1
Abrasion	1	1
Obstruction/Occlusion	1	1
Burn(s)	1	1
Exposure to Body Fluids	1	1
Anaphylactoid / Anaphylaxis	1	1
Missing Value Reason	1	1
Partial thickness (Second Degree) Burn	1	1
Hemothorax	1	1
Low Blood Pressure/ Hypotension	1	1
Pulmonary Embolism	1	1
Bruise/Contusion	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	ICU Medical Inc.	II	Jul-17-2026
6	RanD S.r.l.	II	Jul-09-2021
7	Smisson-Cartledge Biomedical, LLC	I	Mar-26-2021
8	Smiths Medical ASD Inc.	I	Sep-03-2021