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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
Adverse Event Without Identified Device or Use Problem 9 9
Air Leak 9 9
Failure to Deliver 8 8
Defective Device 8 8
Solder Joint Fracture 7 7
Appropriate Term/Code Not Available 7 7
Gas/Air Leak 6 6
Device Contamination with Chemical or Other Material 6 6
Difficult to Open or Close 5 5
Infusion or Flow Problem 5 5
Insufficient Information 5 5
Air/Gas in Device 5 5
Defective Component 5 5
Moisture Damage 4 4
Device Emits Odor 4 4
Detachment Of Device Component 4 4
Inaccurate Delivery 3 3
Failure to Prime 3 3
Self-Activation or Keying 3 3
Sticking 3 3
Loss of or Failure to Bond 3 3
Unintended Movement 3 3
Noise, Audible 3 3
Pressure Problem 3 3
Material Puncture/Hole 3 3
Use of Device Problem 3 3
Improper Flow or Infusion 3 3
Mechanical Problem 3 3
Display or Visual Feedback Problem 3 3
Particulates 3 3
No Flow 3 3
Electromagnetic Interference 2 2
Increase in Pressure 2 2
Decrease in Pressure 2 2
No Display/Image 2 2
Protective Measures Problem 2 2
Positioning Problem 2 2
Device Contamination with Body Fluid 2 2
Therapeutic or Diagnostic Output Failure 2 2
Material Separation 2 2
Intermittent Continuity 2 2
Device Stops Intermittently 2 2
Complete Loss of Power 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
Renal Failure 3 3
Electrolyte Imbalance 3 3
Death 2 2
Unspecified Infection 2 2
Endocarditis 2 2
Overdose 2 2
Malaise 2 2
Sweating 1 1
Hemorrhage/Bleeding 1 1
Cardiac Arrest 1 1
Respiratory Failure 1 1
Fatigue 1 1
No Code Available 1 1
Not Applicable 1 1
No Information 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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