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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
2022 4 4

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 14 14
No Clinical Signs, Symptoms or Conditions 11 12
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
Insufficient 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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