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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reservoir, blood, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass blood reservoir.
Product CodeDTN
Regulation Number 870.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC CARDIAC SURGERY
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM MEDICAL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 12 13
2022 7 8
2023 8 9
2024 10 10
2025 8 8
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Air/Gas in Device 16 18
Obstruction of Flow 10 10
Delivered as Unsterile Product 10 10
Fluid/Blood Leak 4 4
Filtration Problem 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 3
Nonstandard Device 2 2
Leak/Splash 1 1
Break 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Gas/Air Leak 1 1
Inflation Problem 1 1
Misassembled 1 1
Misconnection 1 1
Packaging Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Improper or Incorrect Procedure or Method 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 46 49
Hemorrhage/Bleeding 7 7
Cardiac Arrest 3 3
No Patient Involvement 3 3
Insufficient Information 2 2
No Known Impact Or Consequence To Patient 1 1
Thrombosis/Thrombus 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Circulatory Technology Inc. II Jun-15-2021
2 Maquet Medical Systems USA II May-26-2023
3 Medtronic Perfusion Systems I Mar-17-2021
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