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TPLC
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show TPLC since
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Device
reservoir, blood, cardiopulmonary bypass
Product Code
DTN
Regulation Number
870.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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