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TPLC
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Device
dialyzer, high permeability with or without sealed dialysate system
Product Code
KDI
Regulation Number
876.5860
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAXTER HEALTHCARE CORP
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
4
BAXTER HEALTHCARE CORPORTATION
SUBSTANTIALLY EQUIVALENT
1
BELLCO SRL
SUBSTANTIALLY EQUIVALENT
2
CHF SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
DIALCO MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE REANAL THERAPIES GROUP LLC
SUBSTANTIALLY EQUIVALENT
1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
6
NEPHROS
SUBSTANTIALLY EQUIVALENT
1
NIPRO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NXSTAGE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
NXSTAGE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
OUTSET MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
5
QUANTA DIALYSIS TECHNOLOGIES LTD
SUBSTANTIALLY EQUIVALENT
2
QUANTA DIALYSIS TECHNOLOGIES LTD.
SUBSTANTIALLY EQUIVALENT
1
TECNOIDEAL AMERICA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1587
1587
2020
1633
1633
2021
1944
4385
2022
2180
2180
2023
2708
2708
2024
419
419
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
6472
6717
Adverse Event Without Identified Device or Use Problem
1096
2682
Thermal Decomposition of Device
636
636
Break
423
423
Inadequate Ultra Filtration
306
306
Leak/Splash
282
282
Device Contamination with Chemical or Other Material
275
275
Crack
274
274
Melted
195
195
Disconnection
122
122
Improper or Incorrect Procedure or Method
96
218
Air/Gas in Device
91
213
Smoking
87
87
Obstruction of Flow
76
76
Protective Measures Problem
76
76
Device Displays Incorrect Message
62
62
Device Alarm System
56
56
Detachment of Device or Device Component
46
46
No Apparent Adverse Event
45
45
Improper Flow or Infusion
43
43
Loose or Intermittent Connection
42
42
Material Puncture/Hole
37
37
Therapeutic or Diagnostic Output Failure
37
159
Mechanical Problem
35
35
Sparking
32
32
Patient-Device Incompatibility
32
154
Filtration Problem
28
28
Fire
26
26
Reflux within Device
26
26
No Audible Alarm
25
25
Unexpected Shutdown
25
25
Material Split, Cut or Torn
23
23
Pressure Problem
23
23
Insufficient Information
22
144
Defective Device
20
20
Infusion or Flow Problem
20
20
Use of Device Problem
17
17
Material Rupture
17
139
Product Quality Problem
16
16
Output Problem
16
16
Gas/Air Leak
15
15
Complete Blockage
15
15
No Display/Image
15
15
Display or Visual Feedback Problem
15
15
Calibration Problem
14
14
Defective Component
14
14
No Flow
13
13
Arcing
12
12
Connection Problem
12
12
Device Dislodged or Dislocated
12
134
Filling Problem
11
11
Defective Alarm
11
11
Failure to Prime
10
10
Backflow
9
9
Physical Resistance/Sticking
9
9
Inaccurate Information
9
9
Patient Device Interaction Problem
8
8
Computer Software Problem
8
8
Material Integrity Problem
8
8
Material Separation
8
8
Component Missing
7
7
Material Twisted/Bent
7
7
Coagulation in Device or Device Ingredient
7
7
Increase in Pressure
7
7
Priming Problem
7
7
Appropriate Term/Code Not Available
6
6
Loss of Power
6
6
Use of Incorrect Control/Treatment Settings
6
6
Fracture
5
5
Overheating of Device
5
5
Packaging Problem
5
5
Material Deformation
5
5
Device Sensing Problem
5
5
Biocompatibility
5
5
Unexpected Therapeutic Results
5
5
Material Perforation
5
5
Complete Loss of Power
5
5
Device Fell
4
4
Audible Prompt/Feedback Problem
4
4
Incomplete or Inadequate Connection
4
4
Failure to Disconnect
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Failure of Device to Self-Test
4
4
Failure to Power Up
4
4
Device Appears to Trigger Rejection
4
4
Contamination
4
4
Alarm Not Visible
3
3
False Alarm
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Pumping Stopped
3
3
Energy Output Problem
3
3
Moisture Damage
3
3
Device Emits Odor
3
3
Imprecision
3
3
Misassembled
3
3
Electrical Shorting
3
3
Device Tipped Over
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Inadequate Filtration Process
3
3
Temperature Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5007
5008
No Known Impact Or Consequence To Patient
1237
1237
Hemorrhage/Bleeding
1135
1745
No Consequences Or Impact To Patient
811
811
No Patient Involvement
643
643
Low Blood Pressure/ Hypotension
322
688
Dyspnea
204
449
Hypersensitivity/Allergic reaction
199
199
Insufficient Information
192
436
Cardiac Arrest
179
545
Blood Loss
162
162
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
143
143
Death
128
372
Loss of consciousness
123
611
Nausea
86
453
Itching Sensation
81
203
Hemolysis
76
76
Chest Pain
74
74
Vomiting
73
439
Dizziness
73
73
High Blood Pressure/ Hypertension
59
181
Abdominal Pain
54
176
Diaphoresis
39
40
Low Oxygen Saturation
37
37
Malaise
35
157
Headache
34
156
Reaction
33
33
Tachycardia
33
33
Discomfort
31
31
Anemia
25
25
Rash
24
24
Sweating
24
146
Air Embolism
23
23
Weight Changes
23
23
Chest Tightness/Pressure
23
23
No Code Available
23
23
Chills
21
265
Hypervolemia
21
143
Pain
20
20
Swelling/ Edema
19
19
Bradycardia
19
19
Convulsion/Seizure
18
140
Urticaria
17
139
Hypovolemia
17
17
Syncope/Fainting
16
16
Fatigue
16
16
Cough
16
16
Hypernatremia
16
16
Test Result
15
15
Cardiopulmonary Arrest
15
15
Respiratory Failure
14
14
Anxiety
14
14
Cramp(s) /Muscle Spasm(s)
14
14
Exsanguination
13
135
Myocardial Infarction
11
11
Thrombocytopenia
11
255
Confusion/ Disorientation
10
10
Muscle Weakness
10
132
Hypoxia
10
10
Fall
10
10
Peritonitis
10
10
Fever
10
132
Injury
9
9
Shaking/Tremors
9
9
Diarrhea
9
9
Asthma
9
9
No Information
9
9
Edema
9
9
Respiratory Distress
9
9
Shock
9
131
Swelling
9
9
Cyanosis
8
8
Pallor
8
8
Sepsis
8
130
Loss Of Pulse
8
8
Erythema
8
8
Apnea
7
129
Pulmonary Edema
7
7
Decreased Respiratory Rate
7
7
Hypovolemic Shock
7
7
Seizures
7
7
Cramp(s)
7
7
Respiratory Arrest
7
129
Hot Flashes/Flushes
7
7
Septic Shock
6
6
Weakness
6
6
Palpitations
6
6
Blurred Vision
6
6
Bruise/Contusion
6
6
Fungal Infection
6
6
Abdominal Distention
5
5
Bronchospasm
5
5
Pneumonia
5
5
Distress
5
5
Local Reaction
5
5
Lethargy
5
5
Syncope
5
5
Thrombosis/Thrombus
5
5
Stroke/CVA
5
5
Arrhythmia
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Apr-15-2022
2
Baxter Healthcare Corporation
II
Dec-22-2022
3
Baxter Healthcare Corporation
II
Dec-22-2022
4
Baxter Healthcare Corporation
II
Oct-12-2022
5
Baxter Healthcare Corporation
II
Apr-22-2022
6
Baxter Healthcare Corporation
II
Nov-11-2021
7
Baxter Healthcare Corporation
II
Aug-27-2021
8
Baxter Healthcare Corporation
II
Mar-19-2021
9
Baxter Healthcare Corporation
II
Feb-26-2021
10
Baxter Healthcare Corporation
II
May-21-2020
11
Baxter Healthcare Corporation
II
Apr-30-2020
12
Baxter Healthcare Corporation
II
Feb-28-2020
13
Baxter Healthcare Corporation
II
Nov-04-2019
14
Baxter Healthcare Corporation
II
Oct-30-2019
15
Baxter Healthcare Corporation
II
Jul-01-2019
16
Fresenius Medical Care Holdings, Inc.
I
Oct-06-2023
17
Fresenius Medical Care Holdings, Inc.
II
Dec-20-2022
18
Fresenius Medical Care Holdings, Inc.
II
Jun-30-2022
19
Fresenius Medical Care Holdings, Inc.
II
Apr-20-2020
20
Fresenius Medical Care Holdings, Inc.
II
Mar-20-2020
21
Fresenius Medical Care Renal Therapies Group, LLC
III
Jun-01-2019
22
Nikkiso Ltd - Shizuoka Plant
II
Jan-05-2022
23
NxStage MDS Corporation
II
Feb-27-2024
24
Outset Medical, Inc.
II
Mar-21-2022
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