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
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CLOUDCATH
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	2
IREN-MEDICAL, LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	10779	10779
Adverse Event Without Identified Device or Use Problem	5912	5912
Thermal Decomposition of Device	2785	2785
Protective Measures Problem	1022	1022
Disconnection	687	687
Overfill	562	562
Loose or Intermittent Connection	406	406
Air/Gas in Device	293	293
Detachment of Device or Device Component	257	257
Failure to Disconnect	255	255
Device Contamination with Chemical or Other Material	228	228
Material Puncture/Hole	214	214
Material Split, Cut or Torn	199	199
Component Missing	172	172
Improper Flow or Infusion	130	130
Break	118	118
Crack	106	106
Improper or Incorrect Procedure or Method	96	96
Sparking	81	81
Fitting Problem	75	75
Incomplete or Inadequate Connection	71	71
Unintended Electrical Shock	38	38
Connection Problem	33	33
Smoking	33	33
Scratched Material	29	29
Output Problem	27	27
Melted	23	23
Material Separation	16	16
Material Twisted/Bent	14	14
Material Deformation	12	12
Material Rupture	11	11
Component Misassembled	9	9
Excessive Heating	9	9
Leak/Splash	8	8
Obstruction of Flow	8	8
Fire	7	7
Therapeutic or Diagnostic Output Failure	5	5
Insufficient Information	5	5
Malposition of Device	5	5
Positioning Problem	4	4
Noise, Audible	4	4
Defective Component	4	4
Misconnection	4	4
Contamination	3	3
Material Integrity Problem	3	3
Defective Device	3	3
Material Perforation	3	3
Intermittent Shock/Stimulation	3	3
Filling Problem	3	3
Use of Device Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12215	12215
Peritonitis	3917	3917
No Known Impact Or Consequence To Patient	2870	2870
Abdominal Pain	2084	2084
No Consequences Or Impact To Patient	1064	1064
Unspecified Infection	515	515
Insufficient Information	430	430
Increased Intra-Peritoneal Volume (IIPV)	383	383
Dyspnea	314	314
Hernia	249	249
No Patient Involvement	234	234
Nausea	221	221
Hypervolemia	196	196
Vomiting	171	171
Cardiac Arrest	161	161
Abdominal Distention	154	154
Death	120	120
Fever	116	116
Pain	112	112
Diarrhea	91	91
Fungal Infection	79	79
Malaise	72	72
No Information	71	71
Low Blood Pressure/ Hypotension	70	70
Swelling/ Edema	62	62
Sepsis	60	60
Constipation	57	57
Chest Pain	53	53
Confusion/ Disorientation	52	52
Pulmonary Edema	49	49
Fatigue	43	43
Myocardial Infarction	43	43
Discomfort	39	39
Pneumonia	32	32
High Blood Pressure/ Hypertension	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	31	31
Electrolyte Imbalance	29	29
Pleural Effusion	28	28
Dizziness	26	26
Heart Failure/Congestive Heart Failure	25	25
Loss of consciousness	23	23
Cramp(s) /Muscle Spasm(s)	23	23
Lethargy	20	20
Respiratory Failure	20	20
Fall	19	19
Hypoglycemia	19	19
Uremia	18	18
Chills	17	17
Weakness	17	17
Dehydration	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	Fresenius Medical Care Holdings, Inc.	II	Nov-07-2020