TPLC - Total Product Life Cycle

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Device	set, administration, for peritoneal dialysis, disposable
Product Code	KDJ
Regulation Number	876.5630
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	2
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7791	7791
Fluid/Blood Leak	2267	2267
Improper or Incorrect Procedure or Method	1641	1641
Disconnection	1540	1540
Detachment of Device or Device Component	1235	1235
Crack	575	575
Break	341	341
Failure to Disconnect	308	308
Loose or Intermittent Connection	272	272
Difficult to Open or Close	220	220
Product Quality Problem	208	208
Connection Problem	178	178
Incomplete or Inadequate Connection	140	140
Fitting Problem	139	139
Material Puncture/Hole	106	106
Unsealed Device Packaging	95	95
Free or Unrestricted Flow	90	90
Device Contamination with Chemical or Other Material	79	79
Tear, Rip or Hole in Device Packaging	65	65
Protective Measures Problem	59	59
Component Missing	52	52
Leak/Splash	46	46
Material Split, Cut or Torn	43	43
Material Separation	41	41
Nonstandard Device	37	37
No Flow	35	35
Mechanical Problem	34	34
Delivered as Unsterile Product	31	31
Packaging Problem	24	24
Improper Flow or Infusion	11	11
Material Deformation	11	11
Material Rupture	9	9
Defective Component	8	8
Component Misassembled	7	7
Material Perforation	7	7
Device Dislodged or Dislocated	6	6
Fracture	6	6
Air/Gas in Device	6	6
Device Damaged Prior to Use	5	5
Scratched Material	5	5
Use of Device Problem	5	5
Device Displays Incorrect Message	5	5
Noise, Audible	5	5
Material Disintegration	4	4
Shipping Damage or Problem	4	4
Migration	3	3
Mechanical Jam	3	3
Misconnection	3	3
Contamination /Decontamination Problem	3	3
Contamination	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Peritonitis	8983	8983
No Clinical Signs, Symptoms or Conditions	4494	4494
Abdominal Pain	1570	1570
No Consequences Or Impact To Patient	1520	1520
Unspecified Infection	637	637
No Known Impact Or Consequence To Patient	314	314
No Patient Involvement	294	294
Fever	289	289
Vomiting	182	182
Diarrhea	147	147
Death	92	92
Pain	76	76
Nausea	75	75
Malaise	64	64
Sepsis	49	49
Low Blood Pressure/ Hypotension	35	35
Cardiac Arrest	33	33
Decreased Appetite	30	30
Fatigue	30	30
Insufficient Information	23	23
Chills	21	21
Constipation	19	19
Muscle Weakness	17	17
Abdominal Distention	17	17
Discomfort	15	15
Dyspnea	15	15
Septic Shock	14	14
Cramp(s) /Muscle Spasm(s)	12	12
Weakness	11	11
Dizziness	11	11
Inflammation	11	11
Lethargy	10	10
Swelling/ Edema	9	9
Bacterial Infection	7	7
Hyperthermia	6	6
Fungal Infection	6	6
Headache	5	5
High Blood Pressure/ Hypertension	5	5
Edema	4	4
Abdominal Cramps	4	4
Confusion/ Disorientation	4	4
Cardiopulmonary Arrest	4	4
Electrolyte Imbalance	3	3
Myocardial Infarction	3	3
Loss of consciousness	3	3
Hypersensitivity/Allergic reaction	3	3
Alteration in Body Temperature	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Weight Changes	3	3
Dysphagia/ Odynophagia	2	2

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