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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 1
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 60
No Information 32
High test results 23
Device displays error message 14
No Known Device Problem 12
Air leak 9
Nonstandard device or device component 5
Improper or incorrect procedure or method 5
Patient-device incompatibility 4
Occlusion within device 4
Use of Incorrect Control Settings 4
Fluid leak 3
Data Issue 3
Shelf life exceeded 2
Product quality issue 2
Clumping in device or device ingredient 2
Contamination during use 2
Programming issue 2
Pumping issue 1
Incorrect display 1
Device expiration issue 1
Device alarm system issue 1
Bleed back 1
Device clogged 1
Incorrect or inadequate result 1
Failure to sense 1
Kinked 1
Leak 1
Device emits odor 1
Device Difficult to Setup or Prepare 1
Decrease in pressure 1
Failure to prime 1
Use of Device Issue 1
Incorrect or inadequate test results 1
Device Contamination with biological material 1
Spark 1
Device handling issue 1
Noise, Audible 1
Difficult to open or close 1
Human-Device Interface Issue 1
Improper device output 1
Improper flow or infusion 1
Material integrity issue 1
Total Device Problems 213

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