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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 MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 36 36
2017 41 41
2018 48 48
2019 53 53
2020 63 63
2021 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 102 102
Device Displays Incorrect Message 56 56
Appropriate Term/Code Not Available 35 35
No Audible Alarm 14 14
Inaccurate Flow Rate 13 13
Infusion or Flow Problem 13 13
No Flow 10 10
Insufficient Flow or Under Infusion 8 8
Improper Flow or Infusion 7 7
Device Operates Differently Than Expected 7 7
Use of Device Problem 4 4
Device Alarm System 4 4
Erratic or Intermittent Display 3 3
Incorrect Measurement 3 3
Mechanical Problem 3 3
Device Operational Issue 3 3
Output Problem 3 3
Unexpected Shutdown 2 2
Gas Leak 2 2
Loss of Power 2 2
Increase in Pressure 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Display or Visual Feedback Problem 2 2
Air Leak 1 1
No Display/Image 1 1
Defective Alarm 1 1
Alarm Not Visible 1 1
Decrease in Pressure 1 1
Output above Specifications 1 1
Labelling, Instructions for Use or Training Problem 1 1
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1
Failure to Shut Off 1 1
Calibration Problem 1 1
Defective Component 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 120 120
No Consequences Or Impact To Patient 102 102
No Clinical Signs, Symptoms or Conditions 65 65
No Known Impact Or Consequence To Patient 5 5
Low Oxygen Saturation 3 3
Hypoventilation 2 2
Hypoxia 1 1
Ischemia 1 1
Abnormal Blood Gases 1 1
Death 1 1
No Information 1 1
Insufficient Information 1 1

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