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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
Inadequate user interface 45
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 20
Programming issue 13
No Information 12
No Known Device Problem 11
Device operates differently than expected 10
Use of Device Issue 9
Nonstandard device or device component 6
Occlusion within device 6
Air leak 5
Patient-device incompatibility 5
Device disinfection or sterilization issue 4
Fluid leak 4
Contamination of device ingredient or reagent 3
High test results 2
Shelf life exceeded 2
Unexpected therapeutic results 2
Device inoperable 2
Device alarm system issue 2
Break 2
Detachment of device component 2
Disconnection 2
False reading from device non-compliance 2
Misassembled by Users 2
No code available 1
Device or device component damaged by another device 1
Difficult to open or close 1
Improper device output 1
Inadequate instructions for non-healthcare professional 1
Temperature issue 1
Infusion or flow issue 1
Kinked 1
Loose or intermittent connection 1
Incorrect or inadequate result 1
Material separation 1
Contamination during use 1
Use of Incorrect Control Settings 1
Material discolored 1
Clumping in device or device ingredient 1
Defective Alarm 1
Insufficient flow or underinfusion 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Device misassembled during manufacturing or shipping 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Total Device Problems 438

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