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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, diagnostic
Regulation Description Automated blood cell separator.
Product CodeGKT
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 17
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 37
HARVEST
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Device operates differently than expected 109
No Known Device Problem 105
No Information 32
Improper or incorrect procedure or method 30
High test results 23
Device displays error message 14
Air leak 9
Filtration issue 6
Nonstandard device or device component 5
Occlusion within device 5
Use of Incorrect Control Settings 4
Patient-device incompatibility 4
Component falling 3
Fluid leak 3
Kinked 3
Data Issue 3
Noise, Audible 2
Improper flow or infusion 2
Programming issue 2
Contamination during use 2
Product quality issue 2
Shelf life exceeded 2
Clumping in device or device ingredient 2
Use of Device Issue 2
Sticking 1
Incorrect or inadequate result 1
Failure to sense 1
Device Contamination with biological material 1
Device misassembled during manufacturing or shipping 1
Difficult to open or close 1
Spark 1
Obstruction within device 1
Incorrect or inadequate test results 1
Leak 1
Device maintenance issue 1
Misassembled 1
Device emits odor 1
Device Difficult to Setup or Prepare 1
Decrease in pressure 1
Failure to prime 1
Incorrect display 1
Device expiration issue 1
Fire 1
Device alarm system issue 1
Bleed back 1
Device clogged 1
Pumping issue 1
Not Applicable 1
Material integrity issue 1
Human-Device Interface Issue 1
Improper device output 1
Device handling issue 1
Total Device Problems 402

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