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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
  1.  K202733  Quantum Ventilation Module
  2.  K210669  Quantum Mini Ventilation Module

MDR Year MDR Reports MDR Events
2020 63 63
2021 77 77
2022 69 69
2023 69 70
2024 78 79
2025 128 140
2026 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 322 323
Infusion or Flow Problem 26 26
No Audible Alarm 24 24
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Output Problem 15 15
Suction Problem 14 21
Device Sensing Problem 14 14
Unexpected Shutdown 10 10
No Flow 9 9
Tear, Rip or Hole in Device Packaging 6 6
Device Alarm System 5 5
No Apparent Adverse Event 5 5
Suction Failure 4 4
Calibration Problem 4 4
Mechanical Problem 3 3
Imprecision 3 3
Inaccurate Delivery 3 3
Increase in Pressure 3 4
Insufficient Flow or Under Infusion 3 3
Incorrect Measurement 3 3
Pressure Problem 2 2
Sensing Intermittently 2 2
Device Contamination with Body Fluid 2 2
No Visual Prompts/Feedback 2 2
Failure to Sense 2 2
Electrical /Electronic Property Problem 2 2
Unintended Application Program Shut Down 2 2
Protective Measures Problem 2 2
Gas/Air Leak 2 2
Under-Sensing 2 2
Imprecise or Erratic Results 2 2
Decrease in Pressure 2 2
Defective Alarm 2 2
Electrical Shorting 2 2
Incorrect Interpretation of Signal 1 1
Unintended System Motion 1 1
Failure to Calibrate 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Failure to Fire 1 1
Low Readings 1 1
Labelling, Instructions for Use or Training Problem 1 1
Poor Visibility 1 1
Inaccurate Flow Rate 1 1
Insufficient Device Problem Information 1 1
Improper Flow or Infusion 1 6
Use of Device Problem 1 1
Application Program Freezes or Fails to Launch 1 1
Failure to Deliver 1 1
Pumping Stopped 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 457 471
No Patient Involvement 26 26
No Consequences Or Impact To Patient 23 23
Low Oxygen Saturation 8 8
Insufficient Information 4 4
Hypoventilation 2 2
Abnormal Blood Gases 2 2
No Known Impact Or Consequence To Patient 2 2
Hypoxia 2 2
Death 1 1
Ischemia 1 1
Cardiac Arrest 1 1
Respiratory Insufficiency 1 1

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