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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dialyzer, capillary, hollow fiber
Regulation Description Hemodialysis system and accessories.
Product CodeFJI
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2020 16 16
2021 12 12
2022 2 2
2023 51 51
2024 153 153
2025 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 227 227
Adverse Event Without Identified Device or Use Problem 43 43
Device Contamination with Chemical or Other Material 16 16
Crack 14 14
Break 12 12
Leak/Splash 2 2
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 225 225
Hypersensitivity/Allergic reaction 37 37
Dyspnea 16 16
No Known Impact Or Consequence To Patient 14 14
Low Blood Pressure/ Hypotension 10 10
Nausea 7 7
Itching Sensation 7 7
Abdominal Pain 5 5
Hemorrhage/Bleeding 5 5
Discomfort 5 5
Dizziness 4 4
Chest Pain 4 4
Vomiting 4 4
Diaphoresis 3 3
Tachycardia 3 3
Fever 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fatigue 2 2
Swelling/ Edema 2 2
Malaise 2 2
Rash 2 2
Chills 2 2
Erythema 2 2
Angioedema 1 1
Hot Flashes/Flushes 1 1
Headache 1 1
Cough 1 1
Muscle Hypotonia 1 1
Insufficient Information 1 1
Numbness 1 1
Cardiac Arrest 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Blood Loss 1 1
Pyrosis/Heartburn 1 1
Anemia 1 1
Skin Inflammation/ Irritation 1 1
Wheezing 1 1
Hemolysis 1 1
Syncope/Fainting 1 1
High Blood Pressure/ Hypertension 1 1
Hiccups 1 1

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