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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
Inadequate user interface 134
Data Issue 120
No Known Device Problem 61
Excess flow or overinfusion 38
Improper or incorrect procedure or method 36
Incorrect software programming calculations 35
Device displays error message 26
Patient Data Issue 24
Programming issue 13
No Information 13
Device operates differently than expected 10
Use of Device Issue 9
Nonstandard device or device component 6
Occlusion within device 6
Fluid leak 5
Patient-device incompatibility 5
Air leak 5
Device disinfection or sterilization issue 4
Contamination of device ingredient or reagent 3
Device misassembled during manufacturing or shipping 2
High test results 2
Misassembled by Users 2
Device alarm system issue 2
Detachment of device component 2
Break 2
Disconnection 2
False reading from device non-compliance 2
Shelf life exceeded 2
Unexpected therapeutic results 2
Device inoperable 2
Incorrect or inadequate result 1
Material separation 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Insufficient flow or underinfusion 1
Defective component 1
Component missing 1
Obstruction within device 1
Failure to calibrate 1
Incorrect or inadequate test results 1
Clumping in device or device ingredient 1
Kinked 1
Leak 1
Loose or intermittent connection 1
Misassembled 1
Component falling 1
Contamination during use 1
Use of Incorrect Control Settings 1
Material discolored 1
Defective Alarm 1
Blockage within device or device component 1
No code available 1
Temperature issue 1
Infusion or flow issue 1
Detachment of device or device component 1
Device or device component damaged by another device 1
Device sensing issue 1
Difficult to open or close 1
Improper device output 1
Inadequate instructions for non-healthcare professional 1
Total Device Problems 605

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