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	7345	7346
Fluid/Blood Leak	2412	2412
Detachment of Device or Device Component	2287	2287
Improper or Incorrect Procedure or Method	1666	1666
Disconnection	1522	1523
Crack	613	613
Failure to Disconnect	447	448
Break	385	385
Difficult to Open or Close	344	344
Product Quality Problem	236	236
Loose or Intermittent Connection	227	227
Connection Problem	148	148
Incomplete or Inadequate Connection	140	140
Free or Unrestricted Flow	137	137
Fitting Problem	133	133
Material Puncture/Hole	106	106
Unsealed Device Packaging	99	99
Device Contamination with Chemical or Other Material	91	91
Protective Measures Problem	69	69
Tear, Rip or Hole in Device Packaging	66	66
Leak/Splash	60	60
No Flow	60	60
Component Missing	52	52
Material Separation	41	41
Material Split, Cut or Torn	40	40
Nonstandard Device	37	37
Delivered as Unsterile Product	31	31
Packaging Problem	22	22
Material Rupture	14	14
Material Deformation	12	12
Mechanical Problem	12	12
Air/Gas in Device	10	10
Defective Component	10	10
Device Damaged Prior to Use	9	9
Fracture	7	7
Component Misassembled	7	7
Improper Flow or Infusion	7	7
Material Perforation	7	7
Scratched Material	6	6
Device Dislodged or Dislocated	6	6
Noise, Audible	5	5
Mechanical Jam	5	5
Separation Problem	4	4
Material Disintegration	4	4
Unintended Movement	4	4
Misconnection	4	4
Use of Device Problem	4	4
Shipping Damage or Problem	4	4
Contamination	4	4
Material Twisted/Bent	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Peritonitis	8602	8603
No Clinical Signs, Symptoms or Conditions	6686	6687
Abdominal Pain	1871	1871
No Consequences Or Impact To Patient	952	952
Unspecified Infection	654	654
Fever	280	280
No Known Impact Or Consequence To Patient	271	271
Vomiting	224	224
Diarrhea	156	156
No Patient Involvement	128	128
Nausea	83	83
Pain	72	72
Death	66	66
Malaise	64	64
Sepsis	54	54
Decreased Appetite	47	47
Fatigue	45	45
Low Blood Pressure/ Hypotension	41	41
Cardiac Arrest	34	34
Chills	28	28
Constipation	26	26
Insufficient Information	26	26
Abdominal Distention	26	26
Muscle Weakness	19	19
Swelling/ Edema	18	18
Discomfort	18	18
Dyspnea	17	17
Septic Shock	16	16
Cramp(s) /Muscle Spasm(s)	14	14
Lethargy	12	12
Dizziness	10	10
Bacterial Infection	9	9
Inflammation	8	8
Abdominal Cramps	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Hyperthermia	6	6
Fungal Infection	6	6
Confusion/ Disorientation	5	5
Weakness	5	5
High Blood Pressure/ Hypertension	4	4
Headache	4	4
Myocardial Infarction	4	4
Cough	4	4
Shaking/Tremors	4	4
Electrolyte Imbalance	4	4
Chest Pain	4	4
Ambulation Difficulties	3	3
Weight Changes	3	3
Fibrosis	3	3
Shock	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