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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric hemodialysis system
Definition For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.
Product CodeQIR
Regulation Number 876.5861
Device Class 2


Premarket Reviews
ManufacturerDecision
BELLCO SRL (NOW PART OF MEDTRONIC, INC)
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Protective Measures Problem 3 3
Product Quality Problem 2 2
Leak/Splash 2 2
Loss of Power 1 1
Coagulation in Device or Device Ingredient 1 1
Display or Visual Feedback Problem 1 1
Fluid/Blood Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pumping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3 3
Hemorrhage/Bleeding 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Anemia 1 1
Ischemia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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