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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
Product CodeKOC
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 56 56
2020 20 20
2021 33 33
2022 26 26
2023 16 16
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 104 104
Thermal Decomposition of Device 19 19
Adverse Event Without Identified Device or Use Problem 15 15
Smoking 13 13
Nonstandard Device 12 12
Patient Device Interaction Problem 7 7
Fire 5 5
Overheating of Device 5 5
Device Emits Odor 3 3
Melted 3 3
Disconnection 1 1
Leak/Splash 1 1
Break 1 1
Material Puncture/Hole 1 1
Therapeutic or Diagnostic Output Failure 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
Display or Visual Feedback Problem 1 1
Device Displays Incorrect Message 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 56 56
No Known Impact Or Consequence To Patient 50 50
Hemorrhage/Bleeding 20 20
Hemolysis 14 14
Genital Bleeding 7 7
No Patient Involvement 4 4
Insufficient Information 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Burn, Thermal 2 2
Hypothermia 2 2
Partial thickness (Second Degree) Burn 2 2
No Consequences Or Impact To Patient 2 2
Respiratory Failure 2 2
Abdominal Pain 1 1
Anemia 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Cardiogenic Shock 1 1
Renal Impairment 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stihler Electronic Gmbh II Jan-23-2019
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