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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
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 1
SPECTRUM MEDICAL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 6 6
2021 12 13
2022 7 7
2023 8 8
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Air/Gas in Device 15 15
Obstruction of Flow 7 7
Gas/Air Leak 6 6
Infusion or Flow Problem 3 3
Leak/Splash 2 2
Pressure Problem 2 2
Collapse 2 2
Misassembled 2 2
Device Dislodged or Dislocated 2 3
Nonstandard Device 2 2
Break 1 1
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Filtration Problem 1 1
Short Fill 1 1
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Twisted/Bent 1 1
Inflation Problem 1 1
Misconnection 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
Free or Unrestricted Flow 1 1
No Apparent Adverse Event 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Gas Output Problem 1 1
Improper or Incorrect Procedure or Method 1 2
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 29
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 6 6
Hemorrhage/Bleeding 4 4
Cardiac Arrest 3 3
No Consequences Or Impact To Patient 3 3
Insufficient Information 1 1
Hypovolemia 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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