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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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 136 136
Thermal Decomposition of Device 8 8
Patient Device Interaction Problem 7 7
Crack 5 5
Fire 4 4
Smoking 3 3
Melted 2 2
Inaccurate Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Blood Loss/Bleeding 88 88
No Clinical Signs, Symptoms or Conditions 63 63
Genital Bleeding 7 7
Low Blood Pressure/ Hypotension 3 3
Respiratory Failure 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Abdominal Pain 1 1
Cardiogenic Shock 1 1
Anemia 1 1
Loss of consciousness 1 1
Renal Impairment 1 1
Insufficient Information 1 1
No Known Impact Or Consequence To Patient 1 1
Exsanguination 1 1
Cardiac Arrest 1 1
Hypothermia 1 1

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