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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 1
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 53 53
2020 63 63
2021 77 77
2022 69 69
2023 69 69
2024 78 78
2025 104 116

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 309 309
Infusion or Flow Problem 25 25
Appropriate Term/Code Not Available 24 24
No Audible Alarm 23 23
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Suction Problem 13 20
Device Sensing Problem 12 12
Output Problem 10 10
No Flow 8 8
Unexpected Shutdown 8 8
Inaccurate Flow Rate 8 8
Tear, Rip or Hole in Device Packaging 6 6
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Suction Failure 4 4
Insufficient Flow or Under Infusion 4 4
Gas/Air Leak 3 3
Inaccurate Delivery 3 3
Increase in Pressure 3 3
Device Contamination with Body Fluid 2 2
Device Alarm System 2 2
Erratic Results 2 2
Failure to Sense 2 2
Unintended Application Program Shut Down 2 2
Protective Measures Problem 2 2
Improper Flow or Infusion 2 7
Under-Sensing 2 2
Electrical Shorting 2 2
Defective Alarm 2 2
Loss of Power 1 1
Electrical /Electronic Property Problem 1 1
Incorrect Interpretation of Signal 1 1
Unintended System Motion 1 1
Failure to Calibrate 1 1
Failure to Fire 1 1
Low Readings 1 1
Labelling, Instructions for Use or Training Problem 1 1
Decrease in Pressure 1 1
Use of Device Problem 1 1
Failure to Deliver 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Component 1 1
Insufficient Information 1 1
Incomplete or Inadequate Connection 1 1
Sensing Intermittently 1 1
Pressure Problem 1 1
Increase in Suction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 390 402
No Patient Involvement 55 55
No Consequences Or Impact To Patient 44 44
Low Oxygen Saturation 6 6
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 3 3
Hypoventilation 2 2
Abnormal Blood Gases 2 2
Hypoxia 2 2
Death 1 1
No Information 1 1
Ischemia 1 1
Cardiac Arrest 1 1
Respiratory Insufficiency 1 1

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