TPLC - Total Product Life Cycle

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Device	system, peritoneal, automatic delivery
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	12806	12806
Adverse Event Without Identified Device or Use Problem	6262	6262
Thermal Decomposition of Device	3798	3798
Protective Measures Problem	1043	1043
Disconnection	824	824
Overfill	726	726
Loose or Intermittent Connection	519	519
Improper Flow or Infusion	274	274
Air/Gas in Device	272	272
Detachment of Device or Device Component	269	269
Material Puncture/Hole	249	249
Device Contamination with Chemical or Other Material	231	231
Material Split, Cut or Torn	211	211
Failure to Disconnect	186	186
Component Missing	172	172
Device Displays Incorrect Message	140	140
Break	121	121
Improper or Incorrect Procedure or Method	116	116
Crack	112	112
Sparking	87	87
Fitting Problem	74	74
Incomplete or Inadequate Connection	71	71
Smoking	45	45
Connection Problem	39	39
Unintended Electrical Shock	36	36
Scratched Material	29	29
Output Problem	27	27
Melted	25	25
Material Deformation	17	17
Material Twisted/Bent	15	15
Material Separation	15	15
Material Rupture	11	11
Excessive Heating	9	9
Fire	9	9
Obstruction of Flow	8	8
Component Misassembled	8	8
Leak/Splash	7	7
Insufficient Information	5	5
Material Integrity Problem	5	5
Malposition of Device	5	5
Therapeutic or Diagnostic Output Failure	5	5
Positioning Problem	4	4
Noise, Audible	4	4
Product Quality Problem	3	3
Grounding Malfunction	3	3
Contamination	3	3
Material Perforation	3	3
Misconnection	3	3
Defective Device	3	3
Intermittent Shock/Stimulation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10798	10798
No Known Impact Or Consequence To Patient	6488	6488
Peritonitis	4102	4102
Abdominal Pain	2063	2063
No Consequences Or Impact To Patient	1972	1972
No Patient Involvement	585	585
Unspecified Infection	521	521
Insufficient Information	389	389
Dyspnea	339	339
Increased Intra-Peritoneal Volume (IIPV)	335	335
Hernia	277	277
Nausea	256	256
Abdominal Distention	225	225
Hypervolemia	217	217
Death	207	207
Vomiting	204	204
Cardiac Arrest	150	150
No Information	133	133
Pain	130	130
Fever	126	126
Diarrhea	99	99
Constipation	77	77
Low Blood Pressure/ Hypotension	75	75
Sepsis	68	68
Malaise	67	67
Fungal Infection	59	59
Chest Pain	56	56
Confusion/ Disorientation	54	54
Discomfort	53	53
Swelling/ Edema	52	52
Pulmonary Edema	49	49
Myocardial Infarction	46	46
High Blood Pressure/ Hypertension	43	43
Electrolyte Imbalance	43	43
Fatigue	39	39
Pleural Effusion	31	31
Pneumonia	31	31
Chills	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Loss of consciousness	27	27
Dizziness	24	24
No Code Available	24	24
Fall	24	24
Weakness	22	22
Hypoxia	22	22
Heart Failure/Congestive Heart Failure	19	19
Swelling	19	19
Edema	19	19
Hypoglycemia	18	18
Respiratory Failure	18	18

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	Baxter Healthcare Corporation	II	Oct-03-2019
6	Baxter Healthcare Corporation	II	Feb-20-2019
7	Fresenius Medical Care Holdings, Inc.	III	Dec-26-2023
8	Fresenius Medical Care Holdings, Inc.	II	Jul-16-2021
9	Fresenius Medical Care Holdings, Inc.	II	Nov-07-2020
10	Fresenius Medical Care Renal Therapies Group, LLC	II	Aug-05-2019