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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, blood circuit, hemodialysis
Regulation Description Hemodialysis system and accessories.
Product CodeKOC
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 33 33
2022 26 26
2023 16 16
2024 18 18
2025 49 49
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 130 130
Thermal Decomposition of Device 8 8
Patient Device Interaction Problem 7 7
Fire 4 4
Smoking 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Melted 2 2
Break 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
Detachment of Device or Device Component 1 1
Computer Software Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 86 86
No Clinical Signs, Symptoms or Conditions 58 58
Genital Bleeding 7 7
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Failure 2 2
Abdominal Pain 1 1
Exsanguination 1 1
Anemia 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Cardiogenic Shock 1 1
Insufficient Information 1 1
Hypothermia 1 1
Renal Impairment 1 1
Loss of consciousness 1 1

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