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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
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 68 68
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 220 220
Appropriate Term/Code Not Available 24 24
No Audible Alarm 21 21
Infusion or Flow Problem 20 20
No Flow 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Inaccurate Flow Rate 7 7
No Apparent Adverse Event 5 5
Unexpected Shutdown 4 4
Mechanical Problem 4 4
Insufficient Flow or Under Infusion 4 4
Device Sensing Problem 3 3
Output Problem 3 3
Protective Measures Problem 2 2
Gas/Air Leak 2 2
Increase in Pressure 2 2
Device Alarm System 2 2
Defective Alarm 2 2
Loss of Power 1 1
Decrease in Pressure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Electrical Shorting 1 1
Suction Problem 1 1
Defective Component 1 1
Inaccurate Delivery 1 1
Low Readings 1 1
Improper Flow or Infusion 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 224 224
No Patient Involvement 55 55
No Consequences Or Impact To Patient 44 44
Low Oxygen Saturation 5 5
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 3 3
Hypoventilation 2 2
Hypoxia 1 1
Ischemia 1 1
Abnormal Blood Gases 1 1
Death 1 1
No Information 1 1

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