TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BAIN MEDICAL EQUIPMENT (GUANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DIALITY, INC.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OUTSET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITAL HEALTHCARE SDN. BHD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Air/Gas in Device	1732	1732
Fluid/Blood Leak	832	834
Leak/Splash	736	736
Detachment of Device or Device Component	274	274
Material Puncture/Hole	203	203
Crack	74	74
Device Alarm System	66	66
Loose or Intermittent Connection	63	63
Obstruction of Flow	63	63
Adverse Event Without Identified Device or Use Problem	39	39
Contamination /Decontamination Problem	29	29
Break	27	27
Disconnection	22	22
Material Deformation	21	21
Degraded	18	18
Defective Device	14	14
Pressure Problem	9	9
Defective Component	9	9
Component Missing	8	8
Material Split, Cut or Torn	6	6
Connection Problem	6	6
Protective Measures Problem	5	5
Material Separation	5	5
Gas/Air Leak	5	5
Material Rupture	5	5
Inadequate Filtration Process	4	4
Output Problem	4	4
No Fail-Safe Mechanism	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Improper Flow or Infusion	4	4
Nonstandard Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
No Audible Alarm	3	3
No Flow	2	2
Loss of Power	2	2
Failure of Device to Self-Test	2	2
Defective Alarm	2	2
Device Contamination with Chemical or Other Material	2	2
Tear, Rip or Hole in Device Packaging	2	2
Insufficient Information	2	2
Incomplete or Inadequate Connection	2	2
Reflux within Device	2	2
Separation Problem	2	2
Activation, Positioning or Separation Problem	2	2
Fitting Problem	2	2
Structural Problem	1	1
Infusion or Flow Problem	1	1
Material Twisted/Bent	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Inflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2407	2408
Hemorrhage/Bleeding	1025	1026
Insufficient Information	58	58
Low Blood Pressure/ Hypotension	27	27
Cardiac Arrest	18	18
Loss of consciousness	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Hypersensitivity/Allergic reaction	7	7
Exsanguination	7	7
Dyspnea	7	7
Anemia	7	7
No Consequences Or Impact To Patient	6	6
No Known Impact Or Consequence To Patient	6	6
Low Oxygen Saturation	5	5
Dizziness	5	5
High Blood Pressure/ Hypertension	4	4
Syncope/Fainting	4	4
Fatigue	4	4
Hemolysis	4	4
Nausea	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Bradycardia	3	3
Vomiting	3	3
Chest Pain	3	3
Itching Sensation	3	3
Malaise	3	3
Air Embolism	3	3
Confusion/ Disorientation	2	2
Chemical Exposure	2	2
Hypoxia	2	2
Convulsion/Seizure	2	2
Diaphoresis	2	2
Abdominal Pain	2	2
Decreased Respiratory Rate	2	2
Lethargy	2	2
Obstruction/Occlusion	1	1
Anaphylactoid	1	1
Peritonitis	1	1
Hemolytic Anemia	1	1
Angina	1	1
Foreign Body In Patient	1	1
Thrombosis/Thrombus	1	1
Embolism/Embolus	1	1
Diarrhea	1	1
Jaundice	1	1
Diminished Pulse Pressure	1	1
Coagulation Disorder	1	1
Cough	1	1
Hypovolemic Shock	1	1
Hot Flashes/Flushes	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B BRAUN MEDICAL INC	I	Oct-22-2025
2	B Braun Medical Inc	I	Apr-15-2026
3	B Braun Medical Inc	II	Sep-19-2024
4	Baxter Healthcare Corporation	II	May-26-2021
5	Baxter Healthcare Corporation	II	Feb-16-2021