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TPLC
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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
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2017
4636
4636
2018
3379
3379
2019
2456
2456
2020
2870
2870
2021
3167
3167
2022
964
964
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
9909
9909
Improper or Incorrect Procedure or Method
2099
2099
Fluid Leak
1872
1872
Disconnection
1410
1410
Crack
633
633
Detachment of Device or Device Component
497
497
Break
328
328
Loose or Intermittent Connection
299
299
Product Quality Problem
199
199
Failure to Disconnect
153
153
Connection Problem
139
139
Device Contamination with Chemical or Other Material
123
123
Unsealed Device Packaging
106
106
Fitting Problem
93
93
Difficult to Open or Close
77
77
Component Missing
72
72
Material Puncture/Hole
72
72
Incomplete or Inadequate Connection
63
63
Packaging Problem
53
53
Tear, Rip or Hole in Device Packaging
50
50
Leak/Splash
45
45
Misassembled
44
44
Material Separation
41
41
Material Split, Cut or Torn
39
39
Mechanical Problem
38
38
Device Displays Incorrect Message
36
36
Free or Unrestricted Flow
31
31
Protective Measures Problem
27
27
Delivered as Unsterile Product
27
27
Improper Flow or Infusion
25
25
No Flow
24
24
Device Operates Differently Than Expected
24
24
Hole In Material
24
24
Material Deformation
13
13
Cut In Material
9
9
Device Dislodged or Dislocated
6
6
Radiation Underexposure
5
5
Material Rupture
5
5
Material Perforation
5
5
Defective Component
5
5
Component Misassembled
5
5
Misconnection
4
4
Fracture
4
4
Detachment Of Device Component
3
3
Shipping Damage or Problem
3
3
Mechanical Jam
3
3
Device Packaging Compromised
3
3
Separation Problem
3
3
Insufficient Information
2
2
Expiration Date Error
2
2
Device Markings/Labelling Problem
2
2
Scratched Material
2
2
Material Twisted/Bent
2
2
Use of Device Problem
2
2
Contamination
2
2
Partial Blockage
2
2
Labelling, Instructions for Use or Training Problem
2
2
Kinked
2
2
Difficult to Flush
1
1
Restricted Flow rate
1
1
Complete Blockage
1
1
Device Damaged Prior to Use
1
1
Sticking
1
1
Suction Problem
1
1
Nonstandard Device
1
1
Failure to Prime
1
1
Material Integrity Problem
1
1
Infusion or Flow Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Operating System Becomes Nonfunctional
1
1
Expulsion
1
1
Structural Problem
1
1
Separation Failure
1
1
Defective Device
1
1
Overfill
1
1
Obstruction of Flow
1
1
Incomplete or Missing Packaging
1
1
Device Handling Problem
1
1
Positioning Problem
1
1
Air/Gas in Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Peritonitis
11458
11458
No Consequences Or Impact To Patient
2668
2668
No Clinical Signs, Symptoms or Conditions
1592
1592
Abdominal Pain
1457
1457
No Patient Involvement
595
595
No Known Impact Or Consequence To Patient
569
569
Unspecified Infection
552
552
Fever
293
293
Vomiting
177
177
Death
173
173
Diarrhea
148
148
Nausea
77
77
Sepsis
69
69
Malaise
68
68
Pain
65
65
Weakness
27
27
Cardiac Arrest
25
25
Low Blood Pressure/ Hypotension
23
23
Inflammation
22
22
Chills
20
20
Septic Shock
14
14
Fatigue
14
14
Abdominal Distention
12
12
Constipation
10
10
Dyspnea
10
10
Discomfort
10
10
Dizziness
8
8
Multiple Organ Failure
7
7
Lethargy
6
6
Edema
6
6
Dehydration
5
5
Cardiopulmonary Arrest
5
5
Hyperthermia
5
5
Injury
5
5
Myocardial Infarction
5
5
Abdominal Cramps
5
5
Insufficient Information
5
5
Decreased Appetite
4
4
Weight Changes
4
4
Rash
4
4
Fungal Infection
4
4
Bacterial Infection
4
4
Headache
3
3
Muscle Weakness
3
3
Distress
3
3
Loss of consciousness
3
3
Electrolyte Imbalance
3
3
Swelling
3
3
Shaking/Tremors
3
3
Confusion/ Disorientation
3
3
Pallor
2
2
Cramp(s) /Muscle Spasm(s)
2
2
Alteration in Body Temperature
2
2
Tachycardia
2
2
Thyroid Problems
2
2
Cramp(s)
2
2
Burning Sensation
2
2
Itching Sensation
2
2
Dysphagia/ Odynophagia
2
2
Hyperplasia
2
2
Hypersensitivity/Allergic reaction
2
2
High Blood Pressure/ Hypertension
2
2
Stroke/CVA
2
2
Chest Pain
2
2
Fainting
2
2
Fall
2
2
Encephalopathy
1
1
Purulent Discharge
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Syncope
1
1
Abscess
1
1
Arrhythmia
1
1
Hypoglycemia
1
1
Hemorrhage/Bleeding
1
1
Muscle Spasm(s)
1
1
Necrosis
1
1
Immunodeficiency
1
1
Peritoneal Laceration(s)
1
1
Pleural Effusion
1
1
Shock
1
1
Suffocation
1
1
Dermatomyositis
1
1
Cardiogenic Shock
1
1
Discharge
1
1
Myalgia
1
1
Viral Infection
1
1
Sweating
1
1
Chest Tightness/Pressure
1
1
Sore Throat
1
1
Reaction
1
1
No Information
1
1
Low Oxygen Saturation
1
1
Ambulation Difficulties
1
1
Loss Of Pulse
1
1
Thromboembolism
1
1
Nervous System Injury
1
1
Spinal Arachnoiditis
1
1
Cough
1
1
Respiratory Arrest
1
1
Hyponatremia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Mar-29-2022
2
Baxter Healthcare Corporation
II
Feb-08-2022
3
Baxter Healthcare Corporation
II
Jan-04-2021
4
Baxter Healthcare Corporation
II
Jun-02-2017
5
Fresenius Medical Care Holdings, Inc.
II
Jul-16-2021
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