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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
QUARA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K212688  Quantum PureFlow Standard Heat Exchanger, Quantum ...
  2.  K220110  Quantum PureFlow Standard Heat Exchanger and Quant ...

MDR Year MDR Reports MDR Events
2019 35 35
2020 33 33
2021 11 11
2022 23 23
2023 19 19
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 36 36
Device Displays Incorrect Message 19 19
Leak/Splash 8 8
Device Sensing Problem 6 6
Defective Device 6 6
Air/Gas in Device 5 5
Gas/Air Leak 5 5
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Use of Device Problem 3 3
Material Puncture/Hole 3 3
Defective Component 3 3
Material Separation 2 2
Loss of Power 2 2
Excess Flow or Over-Infusion 2 2
Inaccurate Delivery 2 2
Infusion or Flow Problem 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Improper Flow or Infusion 1 1
Data Problem 1 1
Noise, Audible 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
No Flow 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Pressure 1 1
Output Problem 1 1
Pressure Problem 1 1
Obstruction of Flow 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Emits Odor 1 1
Particulates 1 1
Device Alarm System 1 1
Backflow 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Pumping Stopped 1 1
Microbial Contamination of Device 1 1
Solder Joint Fracture 1 1
Failure to Deliver 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 55 55
No Clinical Signs, Symptoms or Conditions 51 51
Insufficient Information 7 7
No Patient Involvement 5 5
Electrolyte Imbalance 3 3
Overdose 2 2
Bacterial Infection 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 1 1
Blood Loss 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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