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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device kit, repair, catheter, hemodialysis
Regulation Description Blood access device and accessories.
Definition Hemodialysis Tray
Product CodeNFK
Regulation Number 876.5540
Device Class 2

MDR Year MDR Reports MDR Events
2022 18 18
2023 4 4
2024 19 19
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 34 34
Break 15 15
Fluid/Blood Leak 4 4
Leak/Splash 3 3
Material Deformation 2 2
Disconnection 1 1
Fitting Problem 1 1
Material Split, Cut or Torn 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
Ventricular Fibrillation 2 2
Asystole 2 2
Hemorrhage/Bleeding 2 2
Diminished Pulse Pressure 1 1
Cardiac Arrest 1 1

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