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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, blood, dialysis
Regulation Description Hemodialysis system and accessories.
Product CodeFKJ
Regulation Number 876.5820
Device Class 2

Device Problems
Filtration Problem 33
Inadequate Ultra Filtration 12
Calibration Problem 5
Device Alarm System 4
Use of Device Problem 2
Device Sensing Problem 1
Computer Software Problem 1
Insufficient Information 1
Device Operational Issue 1
Temperature Problem 1
Display Difficult to Read 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 63


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