TPLC - Total Product Life Cycle

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Device	set, i.v. fluid transfer
Regulation Description	Intravascular administration set.
Product Code	LHI
Regulation Number	880.5440
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVCARE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AEA SRL
	SUBSTANTIALLY EQUIVALENT	1
ASSET MEDIKAL
	SUBSTANTIALLY EQUIVALENT	1
ASSET MEDIKAL TASARIM SANAYI VE TICARET A.S.
	SUBSTANTIALLY EQUIVALENT	1
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
	SUBSTANTIALLY EQUIVALENT	1
CARE FUSION
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU QIANTANG LONGYUE BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ICU MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
IPAX, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	1
MICROTEK MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
OMNICELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SFM MEDICAL DEVICES GMBH
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI LINGFU TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOL-MILLENNIUM MEDICAL GROUP
	SUBSTANTIALLY EQUIVALENT	1
TAKEDA PHARMACEUTICALS
	SUBSTANTIALLY EQUIVALENT	1
WEST PHARMA SERVICES IL, LTD.
	SUBSTANTIALLY EQUIVALENT	5
WEST PHARMACEUTICAL SERVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
YUKON MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	2425	2465
Device Contamination with Chemical or Other Material	1814	1818
Device Displays Incorrect Message	247	388
Infusion or Flow Problem	222	378
Air/Gas in Device	222	229
Protective Measures Problem	141	260
Leak/Splash	139	146
Defective Device	128	181
Contamination /Decontamination Problem	121	121
Defective Component	81	128
Free or Unrestricted Flow	79	79
Nonstandard Device	77	680
Device Alarm System	74	128
Break	73	90
Contamination	72	72
Output Problem	67	152
Material Puncture/Hole	66	66
Detachment of Device or Device Component	51	52
Therapeutic or Diagnostic Output Failure	49	80
Disconnection	42	57
No Flow	33	45
Display or Visual Feedback Problem	30	52
Complete Blockage	22	22
Obstruction of Flow	22	34
Unsealed Device Packaging	21	21
Improper Flow or Infusion	17	25
Component Missing	17	18
Backflow	16	16
Crack	15	31
Tear, Rip or Hole in Device Packaging	15	15
Use of Device Problem	15	21
Pressure Problem	15	43
Loose or Intermittent Connection	14	14
Delivered as Unsterile Product	14	14
Connection Problem	13	14
Device Difficult to Setup or Prepare	13	18
Insufficient Flow or Under Infusion	12	42
Noise, Audible	12	33
Material Twisted/Bent	11	24
Illegible Information	11	11
Pumping Stopped	11	16
Product Quality Problem	10	16
Fitting Problem	10	10
Patient Device Interaction Problem	10	13
Insufficient Information	9	16
Inaccurate Delivery	9	24
Material Split, Cut or Torn	9	9
Increase in Pressure	9	17
Material Rupture	8	9
Adverse Event Without Identified Device or Use Problem	8	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5573	6102
Insufficient Information	527	780
No Patient Involvement	116	116
Dyspnea	37	312
Headache	34	104
No Consequences Or Impact To Patient	25	25
Pain	21	47
Diarrhea	19	50
Dizziness	17	66
Fatigue	13	52
Nausea	11	67
Malaise	10	73
Chest Pain	9	21
Unspecified Infection	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	22
Hot Flashes/Flushes	4	6
Swelling/ Edema	4	23
Abdominal Pain	3	3
Arrhythmia	3	7
Unspecified Respiratory Problem	3	15
Cough	3	6
Anxiety	3	8
Tachycardia	3	3
Vomiting	3	10
Decreased Appetite	2	2
Hypervolemia	2	3
Low Oxygen Saturation	2	5
Low Blood Pressure/ Hypotension	2	3
Respiratory Insufficiency	2	7
Hemorrhage/Bleeding	2	3
Hypoxia	2	26
Hypoglycemia	2	2
Electrolyte Imbalance	2	3
Cardiac Arrest	2	2
Peripheral Edema	2	9
Itching Sensation	2	13
Sepsis	2	2
Syncope/Fainting	2	22
Skin Discoloration	1	2
Rash	1	12
Pallor	1	2
Fever	1	1
Foreign Body In Patient	1	1
Thrombosis/Thrombus	1	1
Chemical Exposure	1	1
Purulent Discharge	1	1
Anemia	1	1
Erythema	1	1
Vertigo	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Mar-07-2022
2	Baxter Healthcare Corporation	I	Sep-19-2024
3	Baxter Healthcare Corporation	I	Feb-16-2024
4	Baxter Healthcare Corporation	II	Aug-24-2022
5	International Medical Industries, Inc.	II	Jan-07-2023
6	Omnicell, Inc.	II	Apr-04-2025
7	West Pharmaceutical Services AZ, Inc.	II	Nov-01-2024