TPLC - Total Product Life Cycle

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Device	system, peritoneal, automatic delivery
Regulation Description	Peritoneal dialysis system and accessories.
Product Code	FKX
Regulation Number	876.5630
Device Class	2

Premarket Reviews
Manufacturer	Decision
BYONYKS PVT, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CLOUDCATH
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	2
IREN-MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIMERGENT, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	9430	9437
Adverse Event Without Identified Device or Use Problem	6436	6436
Thermal Decomposition of Device	2557	2557
Protective Measures Problem	985	985
Disconnection	640	640
Overfill	505	505
Loose or Intermittent Connection	354	354
Air/Gas in Device	325	325
Failure to Disconnect	267	267
Device Contamination with Chemical or Other Material	255	255
Material Puncture/Hole	224	224
Material Split, Cut or Torn	191	191
Component Missing	181	181
Detachment of Device or Device Component	167	167
Break	116	117
Crack	112	113
Fitting Problem	90	90
Improper or Incorrect Procedure or Method	84	85
Sparking	83	83
Incomplete or Inadequate Connection	77	77
Unintended Electrical Shock	43	43
Connection Problem	39	39
Smoking	34	34
Scratched Material	33	33
Output Problem	27	27
Improper Flow or Infusion	25	25
Melted	18	18
Material Twisted/Bent	15	15
Material Deformation	11	11
Material Rupture	10	10
Excessive Heating	9	9
Material Separation	9	9
Leak/Splash	8	8
Fire	8	8
Obstruction of Flow	7	7
Component Misassembled	7	7
Insufficient Information	6	6
Malposition of Device	6	6
Therapeutic or Diagnostic Output Failure	5	5
Positioning Problem	5	5
Noise, Audible	5	5
Defective Device	4	4
Misconnection	4	4
Contamination	3	3
Gas/Air Leak	3	3
Defective Component	3	3
Material Perforation	3	3
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Device Fell	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14080	14088
Peritonitis	4551	4552
Abdominal Pain	2527	2527
Unspecified Infection	511	511
Increased Intra-Peritoneal Volume (IIPV)	489	489
Insufficient Information	467	467
Dyspnea	302	302
No Known Impact Or Consequence To Patient	279	279
Nausea	254	254
Hernia	242	242
Hypervolemia	213	213
Vomiting	196	196
Cardiac Arrest	172	172
No Consequences Or Impact To Patient	155	155
Abdominal Distention	144	144
Fever	129	129
Pain	106	106
Fungal Infection	102	102
Diarrhea	97	97
Low Blood Pressure/ Hypotension	87	88
Malaise	86	86
Swelling/ Edema	85	85
Sepsis	80	80
Constipation	60	60
Confusion/ Disorientation	59	59
Chest Pain	52	52
Fatigue	46	46
Myocardial Infarction	43	43
Pulmonary Edema	43	43
Cramp(s) /Muscle Spasm(s)	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	37	37
Pneumonia	37	37
Lethargy	34	34
Discomfort	32	32
Pleural Effusion	30	30
Heart Failure/Congestive Heart Failure	29	29
No Patient Involvement	28	28
Fall	27	27
High Blood Pressure/ Hypertension	26	26
Loss of consciousness	25	25
Dizziness	23	23
Electrolyte Imbalance	23	23
Hypoxia	22	22
Septic Shock	21	21
Hypoglycemia	20	20
Urinary Tract Infection	20	20
Stroke/CVA	18	18
Death	18	18
Chills	18	18
Respiratory Failure	17	17

Recalls
Manufacturer		Recall Class	Date Posted
1	BAXTER HEALTHCARE CORPORATION	II	Aug-02-2021
2	Baxter Healthcare Corporation	II	Dec-14-2023
3	Baxter Healthcare Corporation	II	Apr-01-2023
4	Baxter Healthcare Corporation	II	May-27-2022
5	Fresenius Medical Care Holdings, Inc.	III	Dec-26-2023
6	Fresenius Medical Care Holdings, Inc.	II	Jul-16-2021
7	Vantive US Healthcare LLC	II	Oct-29-2025