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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, INC.
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 6 6
2017 3 3
2018 4 4
2019 10 10
2020 6 6
2021 12 13
2022 7 7
2023 7 7
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Air/Gas in Device 12 12
Obstruction of Flow 6 6
Gas/Air Leak 5 5
Infusion or Flow Problem 3 3
Device Dislodged or Dislocated 3 4
Pressure Problem 3 3
Collapse 3 3
Disconnection 3 3
Leak/Splash 2 2
Misassembled 2 2
Detachment Of Device Component 2 2
Nonstandard Device 2 2
Defective Component 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Filtration Problem 1 1
Free or Unrestricted Flow 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Increase in Pressure 1 1
Short Fill 1 1
Improper or Incorrect Procedure or Method 1 2
Device Damaged Prior to Use 1 1
Structural Problem 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Air Leak 1 1
Break 1 1
Misconnection 1 1
Fluid/Blood Leak 1 1
Gas Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 23
No Patient Involvement 16 16
No Known Impact Or Consequence To Patient 9 9
Cardiac Arrest 4 4
Hemorrhage/Bleeding 4 4
No Consequences Or Impact To Patient 4 4
Death 2 2
Low Blood Pressure/ Hypotension 1 1
Thrombus 1 1
Hypovolemia 1 1
Low Oxygen Saturation 1 1
Abdominal Distention 1 1
No Information 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Circulatory Technology Inc II Mar-01-2018
2 Circulatory Technology Inc III Oct-07-2016
3 Circulatory Technology Inc II Sep-15-2016
4 Circulatory Technology Inc II Jun-27-2016
5 Circulatory Technology Inc. II Jun-15-2021
6 Datascope Corporation II May-08-2018
7 Maquet Medical Systems USA II May-26-2023
8 Medtronic Perfusion Systems I Mar-17-2021
9 Medtronic Perfusion Systems II Feb-20-2018
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