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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

MDR Year MDR Reports MDR Events
2018 4 4
2019 10 10
2020 6 6
2021 12 13
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Air/Gas in Device 6 6
Gas/Air Leak 5 5
Infusion or Flow Problem 3 3
Defective Component 2 2
Obstruction of Flow 2 2
Device Dislodged or Dislocated 2 3
Collapse 2 2
Disconnection 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
Short Fill 1 1
Improper or Incorrect Procedure or Method 1 2
Device Damaged Prior to Use 1 1
Misconnection 1 1
Gas Output Problem 1 1
Filtration Problem 1 1
Free or Unrestricted Flow 1 1
Device Markings/Labelling Problem 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 13 13
No Clinical Signs, Symptoms or Conditions 13 14
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 3 3
Hypovolemia 1 1
Insufficient Information 1 1
Thrombus 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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