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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device reservoir, blood, cardiopulmonary bypass
Product CodeDTN
Regulation Number 870.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
SORIN GROUP ITALIA 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 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Air/Gas in Device 10 10
Obstruction of Flow 5 5
Gas/Air Leak 5 5
Infusion or Flow Problem 3 3
Device Dislodged or Dislocated 2 3
Collapse 2 2
Leak/Splash 2 2
Misassembled 2 2
Nonstandard Device 2 2
Pressure Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Break 1 1
Short Fill 1 1
Improper or Incorrect Procedure or Method 1 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Misconnection 1 1
Gas Output Problem 1 1
Filtration Problem 1 1
Free or Unrestricted Flow 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Material Twisted/Bent 1 1
Packaging 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 11 11
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 3 3
Hypovolemia 1 1
Insufficient Information 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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