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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
6
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
899
899
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
6841
7086
Adverse Event Without Identified Device or Use Problem
1125
2711
Thermal Decomposition of Device
659
659
Break
441
441
Inadequate Ultra Filtration
321
321
Crack
289
289
Leak/Splash
282
282
Device Contamination with Chemical or Other Material
280
280
Melted
200
200
Disconnection
125
125
Smoking
97
97
Improper or Incorrect Procedure or Method
96
218
Air/Gas in Device
93
215
Obstruction of Flow
80
80
Protective Measures Problem
78
78
Device Displays Incorrect Message
62
62
Device Alarm System
56
56
Detachment of Device or Device Component
52
52
No Apparent Adverse Event
51
51
Improper Flow or Infusion
44
44
Loose or Intermittent Connection
43
43
Material Puncture/Hole
40
40
Therapeutic or Diagnostic Output Failure
37
159
Mechanical Problem
35
35
Sparking
34
34
Patient-Device Incompatibility
32
154
Filtration Problem
30
30
Fire
27
27
Reflux within Device
26
26
Unexpected Shutdown
26
26
No Audible Alarm
25
25
Material Split, Cut or Torn
24
24
Pressure Problem
23
23
Insufficient Information
22
144
Infusion or Flow Problem
21
21
Defective Device
20
20
Material Rupture
18
140
Use of Device Problem
17
17
Output Problem
16
16
Product Quality Problem
16
16
Complete Blockage
15
15
No Display/Image
15
15
Display or Visual Feedback Problem
15
15
Gas/Air Leak
15
15
Calibration Problem
14
14
Defective Component
14
14
Arcing
13
13
No Flow
13
13
Connection Problem
12
12
Device Dislodged or Dislocated
12
134
Filling Problem
12
12
Defective Alarm
11
11
Failure to Prime
10
10
Backflow
9
9
Patient Device Interaction Problem
9
9
Physical Resistance/Sticking
9
9
Inaccurate Information
9
9
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
Contamination
5
5
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
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
Alarm Not Visible
3
3
False Alarm
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
5197
5198
Hemorrhage/Bleeding
1388
1998
No Known Impact Or Consequence To Patient
1237
1237
No Consequences Or Impact To Patient
811
811
No Patient Involvement
643
643
Low Blood Pressure/ Hypotension
331
697
Hypersensitivity/Allergic reaction
210
210
Dyspnea
210
455
Insufficient Information
200
444
Cardiac Arrest
184
550
Blood Loss
162
162
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
150
150
Death
128
372
Loss of consciousness
126
614
Nausea
89
456
Itching Sensation
84
206
Hemolysis
76
76
Dizziness
75
75
Vomiting
74
440
Chest Pain
74
74
High Blood Pressure/ Hypertension
63
185
Abdominal Pain
56
178
Diaphoresis
42
43
Low Oxygen Saturation
38
38
Headache
35
157
Malaise
35
157
Tachycardia
34
34
Reaction
33
33
Discomfort
32
32
Anemia
27
27
Rash
26
26
Sweating
24
146
Chest Tightness/Pressure
23
23
Weight Changes
23
23
No Code Available
23
23
Air Embolism
23
23
Chills
22
266
Swelling/ Edema
22
22
Syncope/Fainting
21
21
Hypervolemia
21
143
Urticaria
20
142
Pain
20
20
Hypovolemia
19
19
Bradycardia
19
19
Convulsion/Seizure
18
140
Cough
16
16
Hypernatremia
16
16
Fatigue
16
16
Cardiopulmonary Arrest
15
15
Anxiety
15
15
Test Result
15
15
Cramp(s) /Muscle Spasm(s)
15
15
Respiratory Failure
14
14
Exsanguination
13
135
Muscle Weakness
11
133
Myocardial Infarction
11
11
Confusion/ Disorientation
11
11
Thrombocytopenia
11
255
Hypoxia
10
10
Fall
10
10
Fever
10
132
Peritonitis
10
10
Injury
9
9
Respiratory Distress
9
9
Sepsis
9
131
Swelling
9
9
Shock
9
131
Erythema
9
9
Diarrhea
9
9
Edema
9
9
Asthma
9
9
Shaking/Tremors
9
9
No Information
9
9
Loss Of Pulse
8
8
Pallor
8
8
Cyanosis
8
8
Apnea
7
129
Hypovolemic Shock
7
7
Hot Flashes/Flushes
7
7
Seizures
7
7
Pulmonary Edema
7
7
Cramp(s)
7
7
Decreased Respiratory Rate
7
7
Respiratory Arrest
7
129
Thrombosis/Thrombus
6
6
Palpitations
6
6
Blurred Vision
6
6
Fungal Infection
6
6
Pneumonia
6
6
Septic Shock
6
6
Weakness
6
6
Bruise/Contusion
6
6
Syncope
5
5
Arrhythmia
5
5
Stroke/CVA
5
5
Local Reaction
5
5
Distress
5
5
Lethargy
5
5
Bronchospasm
5
5
Abdominal Distention
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.
I
Apr-12-2024
25
Outset Medical, Inc.
II
Mar-21-2022
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