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TPLC
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show TPLC since
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Device
dialyzer, capillary, hollow fiber
Product Code
FJI
Regulation Number
876.5820
Device Class
2
Premarket Reviews
Manufacturer
Decision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
SUBSTANTIALLY EQUIVALENT
1
NIPRO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
632
632
2015
561
561
2016
562
562
2017
182
182
2018
11
11
2019
20
20
2020
16
16
2021
12
12
2022
2
2
2023
51
51
2024
105
105
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
1637
1637
Adverse Event Without Identified Device or Use Problem
446
446
Crack
27
27
Insufficient Information
23
23
Material Rupture
15
15
Occlusion Within Device
14
14
Break
10
10
Leak/Splash
10
10
Device Contamination with Chemical or Other Material
6
6
Device Issue
5
5
Device Displays Incorrect Message
4
4
Loose or Intermittent Connection
2
2
Filtration Problem
2
2
Infusion or Flow Problem
1
1
Material Separation
1
1
Burst Container or Vessel
1
1
Device Contamination with Body Fluid
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Connection Problem
1
1
No Flow
1
1
Hole In Material
1
1
Device Alarm System
1
1
Patient-Device Incompatibility
1
1
Complete Blockage
1
1
Use of Device Problem
1
1
Device Handling Problem
1
1
Appropriate Term/Code Not Available
1
1
Improper Chemical Reaction
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
1475
1475
Itching Sensation
201
201
Reaction
172
172
No Clinical Signs, Symptoms or Conditions
155
155
Hypersensitivity/Allergic reaction
101
101
Death
50
50
Low Blood Pressure/ Hypotension
31
31
Blood Loss
29
29
Loss of consciousness
28
28
Cardiac Arrest
26
26
Nausea
20
20
Cardiopulmonary Arrest
19
19
Dyspnea
18
18
Seizures
18
18
Vomiting
11
11
Fever
10
10
Syncope
9
9
Anxiety
9
9
High Blood Pressure/ Hypertension
8
8
Hemorrhage/Bleeding
8
8
Myocardial Infarction
7
7
Bradycardia
6
6
Erythema
6
6
Chest Pain
6
6
No Code Available
6
6
Tachycardia
6
6
Rash
4
4
Loss Of Pulse
4
4
Thromboembolism
4
4
Anemia
4
4
Dizziness
4
4
Respiratory Distress
4
4
Arrhythmia
4
4
Pulmonary Embolism
4
4
Burning Sensation
3
3
Shaking/Tremors
3
3
Hypervolemia
3
3
First Use Syndrome
3
3
Edema
2
2
Malaise
2
2
Bacterial Infection
2
2
Hypoxia
2
2
No Consequences Or Impact To Patient
2
2
Anaphylactic Shock
2
2
Respiratory Failure
2
2
Diaphoresis
2
2
Sepsis
2
2
Low Oxygen Saturation
2
2
Renal Failure
2
2
Increased Sensitivity
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Fresenius Medical Care Renal Therapies Group, LLC
II
Apr-05-2016
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