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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gas control unit, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass gas control unit.
Product CodeDTX
Regulation Number 870.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
SPECTRUM
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 55
Appropriate Term/Code Not Available 33
Other (for use when an appropriate device code cannot be identified) 29
Gas output problem 12
Inaccurate Flow rate 11
Device Operates Differently Than Expected 9
Improper Flow or Infusion 9
Insufficient Flow or Under Infusion 7
No Flow 6
Alarm, Audible 5
Alarm 4
Infusion or Flow Problem 4
Device Alarm System 4
Use of Device Problem 4
Incorrect Measurement 3
Incorrect, Inadequate or Imprecise Result or Readings 3
Device Operational Issue 3
Erratic or Intermittent Display 3
Output Problem 3
Display or Visual Feedback Problem 2
Loss of Power 2
Device Issue 1
Gas Leak 1
Alarm, Visual 1
Device Handling Problem 1
Output above Specifications 1
Failure to Deliver 1
Decrease in Pressure 1
Calibration Problem 1
No Display / Image 1
Leak / Splash 1
Failure to Shut Off 1
Air Leak 1
Alarm Not Visible 1
Defective Component 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 226


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