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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

MDR Year MDR Reports MDR Events
2020 63 63
2021 77 77
2022 69 69
2023 69 70
2024 78 79
2025 127 139
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 314 315
Infusion or Flow Problem 26 26
No Audible Alarm 24 24
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Suction Problem 14 21
Device Sensing Problem 14 14
Output Problem 13 13
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
Increase in Pressure 3 4
Mechanical Problem 3 3
Incorrect Measurement 3 3
Calibration Problem 3 3
Inaccurate Delivery 3 3
Insufficient Flow or Under Infusion 3 3
Unintended Application Program Shut Down 2 2
Imprecise or Erratic Results 2 2
Device Contamination with Body Fluid 2 2
Electrical Shorting 2 2
Gas/Air Leak 2 2
Pressure Problem 2 2
Protective Measures Problem 2 2
Under-Sensing 2 2
No Visual Prompts/Feedback 2 2
Decrease in Pressure 2 2
Defective Alarm 2 2
Sensing Intermittently 2 2
Failure to Sense 2 2
Failure to Calibrate 1 1
Low Readings 1 1
Failure to Fire 1 1
Incomplete or Inadequate Connection 1 1
Poor Visibility 1 1
Failure to Deliver 1 1
Improper Flow or Infusion 1 6
Defective Component 1 1
Use of Device Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Device Problem Information 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Labelling, Instructions for Use or Training Problem 1 1
Imprecision 1 1
Inaccurate Flow Rate 1 1
Unintended System Motion 1 1
Electrical /Electronic Property Problem 1 1
Pumping Stopped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 444 458
No Patient Involvement 26 26
No Consequences Or Impact To Patient 23 23
Low Oxygen Saturation 8 8
Insufficient Information 3 3
Abnormal Blood Gases 2 2
Hypoxia 2 2
No Known Impact Or Consequence To Patient 2 2
Hypoventilation 2 2
Death 1 1
Cardiac Arrest 1 1
Ischemia 1 1
Respiratory Insufficiency 1 1

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