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TPLC
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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
MDR Year
MDR Reports
MDR Events
2020
2870
2870
2021
3167
3167
2022
2927
2927
2023
2947
2947
2024
3114
3114
2025
246
246
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
6783
6783
Fluid/Blood Leak
2168
2168
Detachment of Device or Device Component
1623
1623
Disconnection
1471
1471
Improper or Incorrect Procedure or Method
1470
1470
Crack
575
575
Failure to Disconnect
368
368
Break
337
337
Difficult to Open or Close
263
263
Loose or Intermittent Connection
216
216
Product Quality Problem
192
192
Connection Problem
145
145
Incomplete or Inadequate Connection
134
134
Fitting Problem
122
122
Free or Unrestricted Flow
103
103
Unsealed Device Packaging
98
98
Material Puncture/Hole
91
91
Device Contamination with Chemical or Other Material
78
78
Tear, Rip or Hole in Device Packaging
64
64
Protective Measures Problem
59
59
Leak/Splash
53
53
Component Missing
50
50
No Flow
44
44
Material Separation
41
41
Nonstandard Device
37
37
Material Split, Cut or Torn
34
34
Delivered as Unsterile Product
29
29
Packaging Problem
20
20
Mechanical Problem
12
12
Material Deformation
11
11
Defective Component
10
10
Material Rupture
8
8
Fracture
7
7
Improper Flow or Infusion
7
7
Air/Gas in Device
7
7
Component Misassembled
7
7
Material Perforation
7
7
Device Dislodged or Dislocated
6
6
Device Damaged Prior to Use
5
5
Noise, Audible
5
5
Material Disintegration
4
4
Scratched Material
4
4
Unintended Movement
4
4
Use of Device Problem
4
4
Misconnection
4
4
Shipping Damage or Problem
4
4
Mechanical Jam
3
3
Contamination /Decontamination Problem
3
3
Migration
3
3
Separation Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Peritonitis
7904
7904
No Clinical Signs, Symptoms or Conditions
5416
5416
Abdominal Pain
1527
1527
No Consequences Or Impact To Patient
952
952
Unspecified Infection
581
581
No Known Impact Or Consequence To Patient
271
271
Fever
245
245
Vomiting
186
186
Diarrhea
132
132
No Patient Involvement
128
128
Nausea
73
73
Pain
67
67
Death
66
66
Malaise
61
61
Sepsis
50
50
Low Blood Pressure/ Hypotension
38
38
Decreased Appetite
33
33
Fatigue
32
32
Cardiac Arrest
30
30
Chills
25
25
Insufficient Information
25
25
Constipation
21
21
Abdominal Distention
20
20
Muscle Weakness
19
19
Swelling/ Edema
17
17
Dyspnea
15
15
Septic Shock
15
15
Cramp(s) /Muscle Spasm(s)
14
14
Discomfort
12
12
Lethargy
11
11
Dizziness
10
10
Bacterial Infection
9
9
Inflammation
8
8
Abdominal Cramps
6
6
Hyperthermia
6
6
Weakness
5
5
Confusion/ Disorientation
4
4
Headache
4
4
High Blood Pressure/ Hypertension
4
4
Myocardial Infarction
4
4
Fungal Infection
4
4
Chest Pain
4
4
Electrolyte Imbalance
4
4
Hypersensitivity/Allergic reaction
3
3
Alteration in Body Temperature
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Stroke/CVA
3
3
Cardiopulmonary Arrest
3
3
Weight Changes
3
3
Cough
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
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