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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heat-exchanger, cardiopulmonary bypass
Product CodeDTR
Regulation Number 870.4240
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUARA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 60 60
2017 69 69
2018 75 75
2019 35 35
2020 33 33
2021 11 11
2022 23 23
2023 19 19
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 93 93
Fluid/Blood Leak 63 63
Leak/Splash 28 28
Device Operates Differently Than Expected 27 27
Device Sensing Problem 17 17
No Apparent Adverse Event 11 11
Loss of Power 11 11
Air Leak 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Defective Device 8 8
Failure to Deliver 8 8
Appropriate Term/Code Not Available 7 7
Solder Joint Fracture 7 7
Device Contamination with Chemical or Other Material 6 6
Gas/Air Leak 6 6
Insufficient Information 5 5
Defective Component 5 5
Difficult to Open or Close 5 5
Air/Gas in Device 5 5
Infusion or Flow Problem 5 5
Detachment Of Device Component 4 4
Device Emits Odor 4 4
Moisture Damage 4 4
Material Puncture/Hole 3 3
Unintended Movement 3 3
Mechanical Problem 3 3
Improper Flow or Infusion 3 3
Pressure Problem 3 3
Use of Device Problem 3 3
Display or Visual Feedback Problem 3 3
No Flow 3 3
Particulates 3 3
Sticking 3 3
Self-Activation or Keying 3 3
Failure to Prime 3 3
Noise, Audible 3 3
Loss of or Failure to Bond 3 3
Inaccurate Delivery 3 3
Decrease in Pressure 2 2
Excess Flow or Over-Infusion 2 2
Failure to Power Up 2 2
Visual Prompts will not Clear 2 2
Material Separation 2 2
Positioning Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Hole In Material 2 2
Protective Measures Problem 2 2
Increase in Pressure 2 2
Device Alarm System 2 2
Device Stops Intermittently 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 156 156
No Known Impact Or Consequence To Patient 81 81
No Clinical Signs, Symptoms or Conditions 53 53
Blood Loss 15 15
No Patient Involvement 11 11
Insufficient Information 7 7
Bacterial Infection 6 6
Fever 4 4
Electrolyte Imbalance 3 3
Renal Failure 3 3
Unspecified Infection 2 2
Death 2 2
Malaise 2 2
Overdose 2 2
Endocarditis 2 2
Sweating 1 1
Fatigue 1 1
Not Applicable 1 1
No Code Available 1 1
No Information 1 1
Cardiac Arrest 1 1
Hemorrhage/Bleeding 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Medical Systems USA II May-26-2023
2 Quest Medical, Inc. II May-22-2020
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