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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
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 20 20
2015 16 16
2016 36 36
2017 41 41
2018 48 48
2019 53 53
2020 63 63
2021 77 77
2022 69 69
2023 69 69
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 227 227
Device Displays Incorrect Message 57 57
Appropriate Term/Code Not Available 35 35
Other (for use when an appropriate device code cannot be identified) 29 29
Infusion or Flow Problem 24 24
No Audible Alarm 21 21
Inaccurate Flow Rate 14 14
No Flow 13 13
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Insufficient Flow or Under Infusion 10 10
Improper Flow or Infusion 9 9
Device Operates Differently Than Expected 9 9
Output Problem 7 7
Unexpected Shutdown 6 6
Device Alarm System 6 6
Tear, Rip or Hole in Device Packaging 6 6
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Use of Device Problem 4 4
Device Operational Issue 3 3
Gas/Air Leak 3 3
Device Sensing Problem 3 3
Incorrect Measurement 3 3
Increase in Pressure 3 3
Erratic or Intermittent Display 3 3
Defective Component 2 2
Erratic Results 2 2
Loss of Power 2 2
Display or Visual Feedback Problem 2 2
Inaccurate Delivery 2 2
Defective Alarm 2 2
Protective Measures Problem 2 2
Low Readings 1 1
Electrical Shorting 1 1
Suction Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Calibration Problem 1 1
Device Handling Problem 1 1
Air Leak 1 1
Device Issue 1 1
Output above Specifications 1 1
Alarm Not Visible 1 1
Failure to Deliver 1 1
Leak/Splash 1 1
No Display/Image 1 1
Incomplete or Inadequate Connection 1 1
Failure to Shut Off 1 1
Insufficient Information 1 1
Decrease in Pressure 1 1
Failure to Sense 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 244 244
No Patient Involvement 122 122
No Consequences Or Impact To Patient 122 122
No Patient involvement 14 14
Low Oxygen Saturation 7 7
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 3 3
Hypoventilation 2 2
Death 1 1
Abnormal Blood Gases 1 1
No Information 1 1
Ischemia 1 1
Hypoxia 1 1

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