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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device separator, automated, blood cell and plasma, therapeutic
Product CodeLKN
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 4
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Data Issue 120
Excess flow or overinfusion 38
Incorrect software programming calculations 35
Device displays error message 25
Patient Data Issue 24
Improper or incorrect procedure or method 15
Programming issue 13
No Information 12
Device operates differently than expected 10
No Known Device Problem 8
Occlusion within device 6
Nonstandard device or device component 6
Air leak 5
Patient-device incompatibility 5
Fluid leak 4
Device disinfection or sterilization issue 4
Contamination of device ingredient or reagent 3
Detachment of device component 2
Misassembled by Users 2
Device alarm system issue 2
Disconnection 2
Shelf life exceeded 2
False reading from device non-compliance 2
Unexpected therapeutic results 2
Device inoperable 2
High test results 2
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Obstruction within device 1
Failure to calibrate 1
Difficult to open or close 1
No code available 1
Clumping in device or device ingredient 1
Contamination during use 1
Material discolored 1
Improper device output 1
Infusion or flow issue 1
Incorrect or inadequate test results 1
Inadequate instructions for non-healthcare professional 1
Temperature issue 1
Break 1
Incorrect or inadequate result 1
Kinked 1
Loose or intermittent connection 1
Insufficient flow or underinfusion 1
Defective Alarm 1
Use of Incorrect Control Settings 1
Material separation 1
Device or device component damaged by another device 1
Device misassembled during manufacturing or shipping 1
Total Device Problems 375

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