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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peritoneal dialysis, single use
Regulation Description Peritoneal dialysis system and accessories.
Product CodeFKO
Regulation Number 876.5630
Device Class 2

MDR Year MDR Reports MDR Events
2021 6 6
2022 1 1
2024 1 1
2025 8 8
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 3 3
Material Split, Cut or Torn 2 2
Malposition of Device 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Fluid/Blood Leak 2 2
Leak/Splash 1 1
Break 1 1
Volume Accuracy Problem 1 1
Material Puncture/Hole 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Migration 1 1
Protective Measures Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 10 10
Unspecified Infection 5 5
Peritonitis 3 3
Abdominal Pain 3 3
Bacterial Infection 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Constipation 2 2
Low Blood Pressure/ Hypotension 1 1
Pericardial Effusion 1 1

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