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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
MDR Year
MDR Reports
MDR Events
2020
4598
4598
2021
5076
5076
2022
4503
4503
2023
3913
3913
2024
3772
3772
2025
262
262
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
10476
10476
Adverse Event Without Identified Device or Use Problem
5658
5658
Thermal Decomposition of Device
2690
2690
Protective Measures Problem
979
979
Disconnection
672
672
Overfill
546
546
Loose or Intermittent Connection
399
399
Air/Gas in Device
291
291
Detachment of Device or Device Component
253
253
Failure to Disconnect
231
231
Device Contamination with Chemical or Other Material
219
219
Material Puncture/Hole
208
208
Material Split, Cut or Torn
196
196
Component Missing
165
165
Improper Flow or Infusion
130
130
Break
113
113
Crack
102
102
Improper or Incorrect Procedure or Method
96
96
Sparking
78
78
Fitting Problem
73
73
Incomplete or Inadequate Connection
70
70
Unintended Electrical Shock
36
36
Smoking
32
32
Connection Problem
31
31
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
Malposition of Device
5
5
Insufficient Information
5
5
Therapeutic or Diagnostic Output Failure
5
5
Misconnection
4
4
Positioning Problem
4
4
Noise, Audible
4
4
Material Integrity Problem
3
3
Material Perforation
3
3
Defective Component
3
3
Defective Device
3
3
Contamination
3
3
Intermittent Shock/Stimulation
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
11734
11734
Peritonitis
3732
3732
No Known Impact Or Consequence To Patient
2870
2870
Abdominal Pain
1988
1988
No Consequences Or Impact To Patient
1064
1064
Unspecified Infection
510
510
Insufficient Information
418
418
Increased Intra-Peritoneal Volume (IIPV)
368
368
Dyspnea
304
304
Hernia
242
242
No Patient Involvement
234
234
Nausea
214
214
Hypervolemia
187
187
Vomiting
166
166
Abdominal Distention
151
151
Cardiac Arrest
148
148
Death
120
120
Fever
114
114
Pain
110
110
Diarrhea
90
90
No Information
71
71
Low Blood Pressure/ Hypotension
68
68
Fungal Infection
67
67
Malaise
65
65
Sepsis
60
60
Swelling/ Edema
58
58
Constipation
56
56
Confusion/ Disorientation
50
50
Chest Pain
49
49
Pulmonary Edema
45
45
Myocardial Infarction
43
43
Fatigue
42
42
Discomfort
37
37
Pneumonia
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
30
30
Electrolyte Imbalance
29
29
High Blood Pressure/ Hypertension
27
27
Pleural Effusion
27
27
Heart Failure/Congestive Heart Failure
23
23
Dizziness
23
23
Loss of consciousness
22
22
Respiratory Failure
20
20
Hypoglycemia
19
19
Fall
18
18
Cramp(s) /Muscle Spasm(s)
18
18
Chills
17
17
Lethargy
17
17
Weakness
17
17
Stroke/CVA
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
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