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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
QUARA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 35 35
2020 33 33
2021 11 11
2022 23 23
2023 19 19
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 35 35
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 50 50
Insufficient Information 6 6
No Patient Involvement 5 5
Electrolyte Imbalance 3 3
Overdose 2 2
Bacterial Infection 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
No Known Impact Or Consequence To Patient 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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