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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
FENWAL INC
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 7
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 7
FRESENIUS KABI USA LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TERUMO BCT
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Adverse Event Without Identified Device or Use Problem 689
Device Operates Differently Than Expected 124
Thermal Decomposition of Device 82
Improper or Incorrect Procedure or Method 80
Use of Device Problem 49
Inadequate User Interface 36
Appropriate Term/Code Not Available 30
Insufficient Information 27
Tube 24
High Test Results 23
Component Falling 22
Device Component Or Accessory 22
Mechanical Problem 21
Device Slipped 17
No Apparent Adverse Event 16
Device Operational Issue 14
Device Displays Incorrect Message 12
Defective Component 12
Human-Device Interface Problem 9
Air Leak 9
Device Misassembled During Manufacturing / Shipping 8
Filtration Problem 6
Device Handling Problem 6
Occlusion Within Device 5
Fluid Leak 5
Nonstandard device 5
Patient-Device Incompatibility 4
Clumping in Device or Device Ingredient 4
Data Problem 3
Use of Incorrect Control Settings 3
Needle 3
Kinked 3
Fire 3
Leak / Splash 2
Sparking 2
Noise, Audible 2
Improper Flow or Infusion 2
Smoking 2
Unintended System Motion 2
Programming Issue 2
Patient Device Interaction Problem 2
Product Quality Problem 2
Shelf Life Exceeded 2
Free or Unrestricted Flow 2
Misassembled 2
Unexpected Therapeutic Results 1
Device Alarm System 1
Computer Software Problem 1
Volume Accuracy Problem 1
Material Integrity Problem 1
Alarm, Visual 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Accessory Incompatible 1
Complete Blockage 1
Unintended Movement 1
PC (Printed Circuit) Board 1
Failure to Sense 1
Sticking 1
Loss of or Failure to Bond 1
Bags 1
Partial Blockage 1
Coagulation in Device or device Ingredient 1
Improper Device Output 1
Device Expiration Issue 1
Contamination During Use 1
Obstruction of Flow 1
Pumping Problem 1
Backflow 1
Device Emits Odor 1
Failure to Align 1
Display or Visual Feedback Problem 1
Device Maintenance Issue 1
Calibration Problem 1
Decrease in Pressure 1
Material Discolored 1
Incomplete or Inadequate Connection 1
Infusion or Flow Problem 1
Insufficient Flow or Under Infusion 1
Device Difficult to Setup or Prepare 1
Connection Problem 1
Material Split, Cut or Torn 1
Electrical Shorting 1
Circuit Failure 1
Charred 1
Loose or Intermittent Connection 1
Incorrect Or Inadequate Test Results 1
Total Device Problems 1441


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