TPLC - Total Product Life Cycle

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Device	set, administration, for peritoneal dialysis, disposable
Regulation Description	Peritoneal dialysis system and accessories.
Product Code	KDJ
Regulation Number	876.5630
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6266	6267
Detachment of Device or Device Component	2350	2350
Fluid/Blood Leak	1969	1969
Improper or Incorrect Procedure or Method	1470	1470
Disconnection	1271	1272
Crack	517	517
Failure to Disconnect	441	442
Difficult to Open or Close	352	352
Break	340	340
Product Quality Problem	205	205
Loose or Intermittent Connection	183	183
Free or Unrestricted Flow	143	143
Connection Problem	124	124
Incomplete or Inadequate Connection	119	119
Fitting Problem	107	107
Material Puncture/Hole	98	98
Unsealed Device Packaging	90	90
Device Contamination with Chemical or Other Material	81	81
Protective Measures Problem	73	73
No Flow	62	62
Leak/Splash	59	59
Tear, Rip or Hole in Device Packaging	58	58
Component Missing	48	48
Nonstandard Device	36	36
Material Split, Cut or Torn	32	32
Delivered as Unsterile Product	20	20
Packaging Problem	17	17
Material Rupture	14	14
Air/Gas in Device	12	12
Material Separation	11	11
Defective Component	10	10
Material Deformation	10	10
Device Damaged Prior to Use	9	9
Fracture	8	8
Component Misassembled	7	7
Scratched Material	6	6
Mechanical Jam	5	5
Material Perforation	5	5
Use of Device Problem	5	5
Noise, Audible	5	5
Shipping Damage or Problem	4	4
Material Disintegration	4	4
Device Dislodged or Dislocated	4	4
Unintended Movement	4	4
Material Twisted/Bent	3	3
Contamination /Decontamination Problem	3	3
Complete Blockage	3	3
Contamination	3	3
Misconnection	3	3
Migration	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Peritonitis	7350	7351
No Clinical Signs, Symptoms or Conditions	7034	7035
Abdominal Pain	1793	1793
Unspecified Infection	627	627
Fever	264	264
Vomiting	205	205
No Consequences Or Impact To Patient	154	154
Diarrhea	145	145
Nausea	91	91
Pain	66	66
Malaise	60	60
Decreased Appetite	58	58
Fatigue	46	46
Sepsis	45	45
Low Blood Pressure/ Hypotension	38	38
Constipation	31	31
Chills	30	30
Insufficient Information	27	27
Abdominal Distention	27	27
Cardiac Arrest	24	24
Muscle Weakness	20	20
Swelling/ Edema	19	19
Discomfort	19	19
No Known Impact Or Consequence To Patient	19	19
Septic Shock	16	16
Dyspnea	15	15
No Patient Involvement	14	14
Cramp(s) /Muscle Spasm(s)	14	14
Lethargy	13	13
Dizziness	11	11
Bacterial Infection	10	10
Inflammation	9	9
Abdominal Cramps	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Fungal Infection	5	5
Death	5	5
Shaking/Tremors	4	4
Cough	4	4
High Blood Pressure/ Hypertension	4	4
Hyperthermia	4	4
Electrolyte Imbalance	4	4
Headache	4	4
Chest Pain	4	4
Alteration in Body Temperature	4	4
Shock	3	3
Hypoglycemia	3	3
Fibrosis	3	3
Myocardial Infarction	3	3
Confusion/ Disorientation	3	3
Dehydration	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Nov-27-2024
2	Baxter Healthcare Corporation	I	Nov-20-2024
3	Baxter Healthcare Corporation	II	Mar-03-2023
4	Baxter Healthcare Corporation	II	May-27-2022
5	Baxter Healthcare Corporation	II	Mar-29-2022
6	Baxter Healthcare Corporation	II	Feb-08-2022
7	Baxter Healthcare Corporation	II	Jan-04-2021
8	Fresenius Medical Care Holdings, Inc.	I	Mar-26-2024
9	Fresenius Medical Care Holdings, Inc.	II	Dec-07-2023
10	Fresenius Medical Care Holdings, Inc.	II	Jul-16-2021