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
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K202796 SANSIN Tubing Sets for Hemodialysis
OUTSET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	674	674
Leak/Splash	380	380
Air/Gas in Device	340	340
Detachment of Device or Device Component	222	222
Material Puncture/Hole	185	185
Crack	57	57
Adverse Event Without Identified Device or Use Problem	46	46
Contamination /Decontamination Problem	32	32
Loose or Intermittent Connection	26	26
Disconnection	23	23
Obstruction of Flow	21	21
Break	19	19
Material Deformation	17	17
Degraded	10	10
Separation Problem	9	9
Material Split, Cut or Torn	7	7
Connection Problem	6	6
Improper or Incorrect Procedure or Method	5	5
Device Alarm System	5	5
Material Separation	5	5
Inadequate Filtration Process	4	4
Defective Component	4	4
No Fail-Safe Mechanism	4	4
Component Missing	4	4
Device Contamination with Chemical or Other Material	3	3
Improper Flow or Infusion	3	3
Gas/Air Leak	3	3
Output Problem	3	3
Pressure Problem	3	3
No Audible Alarm	2	2
Material Rupture	2	2
Tear, Rip or Hole in Device Packaging	2	2
Protective Measures Problem	2	2
Failure of Device to Self-Test	2	2
Loss of Power	2	2
No Flow	2	2
Failure to Deliver	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination	1	1
Unintended Ejection	1	1
Material Twisted/Bent	1	1
Defective Device	1	1
Structural Problem	1	1
Infusion or Flow Problem	1	1
Insufficient Information	1	1
Inflation Problem	1	1
Delivered as Unsterile Product	1	1
Patient-Device Incompatibility	1	1
Complete Blockage	1	1
Pumping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1044	1044
Hemorrhage/Bleeding	488	488
No Known Impact Or Consequence To Patient	150	150
Insufficient Information	36	36
Low Blood Pressure/ Hypotension	25	25
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	10	10
Blood Loss	10	10
Hypersensitivity/Allergic reaction	9	9
Exsanguination	7	7
Anemia	7	7
Dizziness	6	6
Dyspnea	5	5
Low Oxygen Saturation	4	4
High Blood Pressure/ Hypertension	4	4
Syncope/Fainting	4	4
Itching Sensation	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Bradycardia	3	3
No Patient Involvement	3	3
Vomiting	3	3
Chest Pain	3	3
Nausea	3	3
Hemolysis	3	3
Death	3	3
Confusion/ Disorientation	2	2
Chemical Exposure	2	2
Malaise	2	2
Diaphoresis	2	2
Anxiety	2	2
Hypoxia	2	2
Convulsion/Seizure	2	2
Air Embolism	2	2
Abdominal Pain	2	2
Decreased Respiratory Rate	2	2
Hypovolemia	2	2
Obstruction/Occlusion	1	1
Anaphylactoid	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
Coagulation Disorder	1	1
Diarrhea	1	1
Jaundice	1	1

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