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	1
DIALITY, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K243607 Moda-flx Hemodialysis System™ Cartridge (102121-00 ...
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Air/Gas in Device	1149	1149
Fluid/Blood Leak	864	864
Leak/Splash	657	657
Detachment of Device or Device Component	259	259
Material Puncture/Hole	193	193
Crack	65	65
Loose or Intermittent Connection	62	62
Obstruction of Flow	59	59
Adverse Event Without Identified Device or Use Problem	46	46
Contamination /Decontamination Problem	35	35
Device Alarm System	32	32
Disconnection	26	26
Break	25	25
Material Deformation	19	19
Degraded	18	18
Defective Device	14	14
Separation Problem	9	9
Defective Component	9	9
Material Split, Cut or Torn	7	7
Connection Problem	7	7
Component Missing	6	6
Pressure Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Material Separation	5	5
Material Rupture	5	5
Inadequate Filtration Process	4	4
Protective Measures Problem	4	4
Improper Flow or Infusion	4	4
Gas/Air Leak	4	4
No Fail-Safe Mechanism	4	4
No Audible Alarm	3	3
Device Contamination with Chemical or Other Material	3	3
Output Problem	3	3
Complete Blockage	2	2
Tear, Rip or Hole in Device Packaging	2	2
Incomplete or Inadequate Connection	2	2
Failure of Device to Self-Test	2	2
Loss of Power	2	2
Reflux within Device	2	2
No Flow	2	2
Fitting Problem	2	2
Failure to Deliver	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination	1	1
Unintended Ejection	1	1
Material Twisted/Bent	1	1
Insufficient Information	1	1
Structural Problem	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1881	1881
Hemorrhage/Bleeding	796	796
No Known Impact Or Consequence To Patient	150	150
Insufficient Information	53	53
Low Blood Pressure/ Hypotension	27	27
No Consequences Or Impact To Patient	20	20
Cardiac Arrest	20	20
Loss of consciousness	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Blood Loss	10	10
Dyspnea	9	9
Hypersensitivity/Allergic reaction	9	9
Exsanguination	8	8
Anemia	7	7
Dizziness	6	6
Nausea	5	5
Low Oxygen Saturation	4	4
Vomiting	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Itching Sensation	4	4
Hemolysis	4	4
Fatigue	4	4
Syncope/Fainting	4	4
High Blood Pressure/ Hypertension	4	4
Malaise	3	3
Chest Pain	3	3
No Patient Involvement	3	3
Death	3	3
Bradycardia	3	3
Air Embolism	3	3
Chemical Exposure	2	2
Diaphoresis	2	2
Confusion/ Disorientation	2	2
Anxiety	2	2
Hypoxia	2	2
Convulsion/Seizure	2	2
Abdominal Pain	2	2
Decreased Respiratory Rate	2	2
Hypovolemia	2	2
Diminished Pulse Pressure	1	1
Coagulation Disorder	1	1
Anaphylactoid	1	1
Obstruction/Occlusion	1	1
Peritonitis	1	1
Hemolytic Anemia	1	1
Angina	1	1
Rash	1	1
Weakness	1	1
Foreign Body In Patient	1	1
Thrombosis/Thrombus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B BRAUN MEDICAL INC	I	Oct-22-2025
2	B Braun Medical Inc	II	Sep-19-2024
3	Baxter Healthcare Corporation	II	May-26-2021
4	Baxter Healthcare Corporation	II	Feb-16-2021
5	Baxter Healthcare Corporation	II	Jun-01-2020
6	ICU Medical, Inc.	II	Dec-23-2020