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
1. K220935 Digital Dialysis Clinic - Intelligent Dialysis Ass ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	10570	10570
Adverse Event Without Identified Device or Use Problem	5734	5734
Thermal Decomposition of Device	2723	2723
Protective Measures Problem	996	996
Disconnection	675	675
Overfill	549	549
Loose or Intermittent Connection	403	403
Air/Gas in Device	291	291
Detachment of Device or Device Component	256	256
Failure to Disconnect	246	246
Device Contamination with Chemical or Other Material	220	220
Material Puncture/Hole	210	210
Material Split, Cut or Torn	196	196
Component Missing	169	169
Improper Flow or Infusion	130	130
Break	115	115
Crack	103	103
Improper or Incorrect Procedure or Method	96	96
Sparking	80	80
Fitting Problem	73	73
Incomplete or Inadequate Connection	70	70
Unintended Electrical Shock	37	37
Smoking	33	33
Connection Problem	32	32
Scratched Material	28	28
Output Problem	27	27
Melted	23	23
Material Separation	16	16
Material Twisted/Bent	14	14
Material Deformation	12	12
Material Rupture	11	11
Excessive Heating	9	9
Component Misassembled	9	9
Obstruction of Flow	8	8
Fire	7	7
Leak/Splash	7	7
Insufficient Information	5	5
Malposition of Device	5	5
Therapeutic or Diagnostic Output Failure	5	5
Misconnection	4	4
Noise, Audible	4	4
Positioning Problem	4	4
Material Perforation	3	3
Contamination	3	3
Intermittent Shock/Stimulation	3	3
Material Integrity Problem	3	3
Defective Device	3	3
Defective Component	3	3
Filling Problem	3	3
Gas/Air Leak	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11896	11896
Peritonitis	3794	3794
No Known Impact Or Consequence To Patient	2870	2870
Abdominal Pain	2023	2023
No Consequences Or Impact To Patient	1064	1064
Unspecified Infection	510	510
Insufficient Information	423	423
Increased Intra-Peritoneal Volume (IIPV)	371	371
Dyspnea	305	305
Hernia	243	243
No Patient Involvement	234	234
Nausea	218	218
Hypervolemia	188	188
Vomiting	169	169
Abdominal Distention	151	151
Cardiac Arrest	150	150
Death	120	120
Fever	116	116
Pain	110	110
Diarrhea	90	90
Fungal Infection	71	71
No Information	71	71
Low Blood Pressure/ Hypotension	68	68
Malaise	67	67
Sepsis	60	60
Swelling/ Edema	58	58
Constipation	56	56
Confusion/ Disorientation	51	51
Chest Pain	49	49
Pulmonary Edema	47	47
Myocardial Infarction	43	43
Fatigue	43	43
Discomfort	37	37
Pneumonia	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	30
Electrolyte Imbalance	29	29
Pleural Effusion	27	27
High Blood Pressure/ Hypertension	27	27
Dizziness	24	24
Heart Failure/Congestive Heart Failure	23	23
Loss of consciousness	22	22
Cramp(s) /Muscle Spasm(s)	20	20
Respiratory Failure	20	20
Hypoglycemia	19	19
Fall	18	18
Chills	17	17
Weakness	17	17
Stroke/CVA	17	17
Lethargy	17	17
Hypoxia	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	Fresenius Medical Care Holdings, Inc.	II	Nov-07-2020