TPLC - Total Product Life Cycle

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Device	pediatric hemodialysis system
Regulation Description	Pediatric continuous renal replacement therapy 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 Code	QIR
Regulation Number	876.5861
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Smoking	9	9
Display or Visual Feedback Problem	9	9
Adverse Event Without Identified Device or Use Problem	6	6
Protective Measures Problem	6	6
Product Quality Problem	3	3
Device Sensing Problem	3	3
Leak/Splash	2	2
Shipping Damage or Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Pressure Problem	1	1
Pumping Problem	1	1
Device Difficult to Setup or Prepare	1	1
Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	18	18
Insufficient Information	8	8
Hemorrhage/Bleeding	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Skin Discoloration	2	2
Pain	2	2
Thrombocytopenia	2	2
Low Blood Pressure/ Hypotension	2	2
Unspecified Infection	1	1
Sepsis	1	1
Gastrointestinal Hemorrhage	1	1
Ischemia	1	1
Anemia	1	1
Exposure to Body Fluids	1	1