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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

MDR Year MDR Reports MDR Events
2017 3 3
2018 4 4
2019 10 10
2020 6 6
2021 12 13

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Leak 5 5
Air/Gas in Device 4 4
Infusion or Flow Problem 3 3
Device Dislodged or Dislocated 3 4
Pressure Problem 3 3
Disconnection 3 3
Defective Component 2 2
Leak/Splash 2 2
Misassembled 2 2
Nonstandard Device 2 2
Collapse 2 2
Short Fill 1 1
Improper or Incorrect Procedure or Method 1 2
Structural Problem 1 1
Fluid Leak 1 1
Gas Output Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 14 14
No Clinical Signs, Symptoms or Conditions 8 9
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 3 3
Hypovolemia 1 1
Low Oxygen Saturation 1 1
Abdominal Distention 1 1
Cardiac Arrest 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1
Thrombus 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Circulatory Technology Inc II Mar-01-2018
2 Circulatory Technology Inc. II Jun-15-2021
3 Datascope Corporation II May-08-2018
4 Medtronic Perfusion Systems I Mar-17-2021
5 Medtronic Perfusion Systems II Feb-20-2018
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