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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 filter, blood, dialysis
Product CodeFKJ
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 48 48
2017 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Filtration Problem 33 33
Inadequate Ultra Filtration 12 12
Calibration Problem 5 5
Device Alarm System 4 4
Use of Device Problem 2 2
Computer Software Problem 1 1
Display Difficult to Read 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 29 29
Cramp(s) 13 13
Low Blood Pressure/ Hypotension 8 8
Hypernatremia 5 5
Sweating 3 3
Cardiac Arrest 3 3
Death 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Decreased Respiratory Rate 1 1
Blood Loss 1 1
Discomfort 1 1
Hypoglycemia 1 1
Air Embolism 1 1
Hypovolemic Shock 1 1
Myocardial Infarction 1 1
Chills 1 1

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