TPLC - Total Product Life Cycle

show TPLC since

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	9119	9126
Adverse Event Without Identified Device or Use Problem	6020	6020
Thermal Decomposition of Device	2480	2480
Protective Measures Problem	927	927
Disconnection	615	615
Overfill	476	476
Loose or Intermittent Connection	335	335
Air/Gas in Device	315	315
Failure to Disconnect	265	265
Device Contamination with Chemical or Other Material	228	228
Material Puncture/Hole	214	214
Material Split, Cut or Torn	187	187
Component Missing	170	170
Detachment of Device or Device Component	164	164
Crack	108	109
Break	105	106
Fitting Problem	85	85
Sparking	81	81
Improper or Incorrect Procedure or Method	80	81
Incomplete or Inadequate Connection	76	76
Unintended Electrical Shock	40	40
Connection Problem	32	32
Smoking	32	32
Scratched Material	29	29
Output Problem	27	27
Improper Flow or Infusion	24	24
Melted	17	17
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
Component Misassembled	7	7
Obstruction of Flow	7	7
Fire	6	6
Insufficient Information	6	6
Malposition of Device	6	6
Noise, Audible	5	5
Positioning Problem	5	5
Therapeutic or Diagnostic Output Failure	4	4
Defective Device	4	4
Misconnection	4	4
Contamination	3	3
Gas/Air Leak	3	3
Defective Component	3	3
Material Perforation	3	3
Use of Device Problem	2	2
Mechanical Problem	2	2
Display or Visual Feedback Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13560	13568
Peritonitis	4214	4215
Abdominal Pain	2336	2336
Unspecified Infection	506	506
Increased Intra-Peritoneal Volume (IIPV)	459	459
Insufficient Information	456	456
Dyspnea	283	283
No Known Impact Or Consequence To Patient	279	279
Nausea	246	246
Hernia	229	229
Hypervolemia	195	195
Vomiting	182	182
Cardiac Arrest	157	157
No Consequences Or Impact To Patient	155	155
Abdominal Distention	136	136
Fever	116	116
Pain	99	99
Fungal Infection	95	95
Diarrhea	93	93
Low Blood Pressure/ Hypotension	83	84
Malaise	81	81
Swelling/ Edema	73	73
Sepsis	72	72
Constipation	58	58
Confusion/ Disorientation	54	54
Chest Pain	49	49
Fatigue	45	45
Pulmonary Edema	40	40
Myocardial Infarction	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	36
Cramp(s) /Muscle Spasm(s)	35	35
Pneumonia	34	34
Discomfort	31	31
Heart Failure/Congestive Heart Failure	29	29
Pleural Effusion	28	28
No Patient Involvement	28	28
Lethargy	26	26
Fall	23	23
Loss of consciousness	23	23
High Blood Pressure/ Hypertension	22	22
Dizziness	21	21
Septic Shock	21	21
Hypoxia	20	20
Electrolyte Imbalance	20	20
Urinary Tract Infection	20	20
Hypoglycemia	19	19
Death	18	18
Chills	18	18
Stroke/CVA	17	17
Hypersensitivity/Allergic reaction	16	16

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