TPLC - Total Product Life Cycle

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Device	set, tubing, blood, with and without anti-regurgitation valve
Product Code	FJK
Regulation Number	876.5820
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIMESOL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OUTSET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	869	869
Leak/Splash	370	370
Air/Gas in Device	292	292
Detachment of Device or Device Component	196	196
Material Puncture/Hole	179	179
Adverse Event Without Identified Device or Use Problem	90	90
Disconnection	60	60
Crack	54	54
Loose or Intermittent Connection	37	37
Contamination /Decontamination Problem	30	30
Obstruction of Flow	23	23
Break	20	20
Material Deformation	16	16
Connection Problem	12	12
Material Separation	10	10
Degraded	10	10
Air Leak	10	10
Material Split, Cut or Torn	9	9
Separation Problem	9	9
No Fail-Safe Mechanism	8	8
Defective Component	7	7
Insufficient Information	7	7
Device Dislodged or Dislocated	6	6
Device Contamination with Chemical or Other Material	6	6
Hole In Material	5	5
Inadequate Filtration Process	5	5
Gas/Air Leak	5	5
Improper or Incorrect Procedure or Method	5	5
Occlusion Within Device	4	4
Component Missing	4	4
Material Rupture	4	4
Device Displays Incorrect Message	4	4
Device Alarm System	3	3
Improper Flow or Infusion	3	3
Output Problem	3	3
Material Perforation	3	3
Migration or Expulsion of Device	3	3
Pressure Problem	3	3
Device Operates Differently Than Expected	3	3
Split	2	2
Burst Container or Vessel	2	2
Device Operational Issue	2	2
No Audible Alarm	2	2
Coagulation in Device or Device Ingredient	2	2
Failure of Device to Self-Test	2	2
No Flow	2	2
Protective Measures Problem	2	2
Loss of Power	2	2
Tear, Rip or Hole in Device Packaging	2	2
Failure To Adhere Or Bond	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	939	939
Hemorrhage/Bleeding	393	393
No Known Impact Or Consequence To Patient	379	379
Blood Loss	82	82
No Consequences Or Impact To Patient	72	72
Low Blood Pressure/ Hypotension	42	42
Insufficient Information	34	34
Hemolysis	32	32
Cardiac Arrest	30	30
Death	25	25
Loss of consciousness	24	24
Dyspnea	16	16
Exsanguination	15	15
Anemia	13	13
Hypovolemia	12	12
Cardiopulmonary Arrest	12	12
Chest Pain	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Hypersensitivity/Allergic reaction	8	8
No Patient Involvement	8	8
Dizziness	8	8
Nausea	6	6
Syncope	5	5
Confusion/ Disorientation	5	5
Low Oxygen Saturation	4	4
Bradycardia	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Abdominal Pain	4	4
Itching Sensation	4	4
High Blood Pressure/ Hypertension	4	4
Syncope/Fainting	4	4
No Code Available	4	4
Air Embolism	3	3
Foreign Body In Patient	3	3
Vomiting	3	3
Diaphoresis	3	3
Hypervolemia	2	2
Pulmonary Embolism	2	2
Decreased Respiratory Rate	2	2
Unspecified Infection	2	2
Convulsion/Seizure	2	2
Hypoxia	2	2
Sudden Cardiac Death	2	2
Anxiety	2	2
Congestive Heart Failure	2	2
Hyperthermia	2	2
Seizures	2	2
Loss Of Pulse	2	2
Weakness	2	2
Hemolytic Anemia	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	B Braun Medical Inc	II	Sep-19-2024
2	Baxter Healthcare Corporation	II	May-26-2021
3	Baxter Healthcare Corporation	II	Feb-16-2021
4	Baxter Healthcare Corporation	II	Jun-01-2020
5	ICU Medical, Inc.	II	Dec-23-2020
6	Nipro Medical Corporation	II	May-15-2018