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TPLC
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show TPLC since
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Device
filter, blood, cardiopulmonary bypass, arterial line
Product Code
DTM
Regulation Number
870.4260
Device Class
2
Premarket Reviews
Manufacturer
Decision
GISH BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MAQUET CARDIOPULMONARY AG
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
PAREXELINTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TRANSMEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
64
64
2015
34
34
2016
27
27
2017
15
15
2018
23
23
2019
5
5
2020
1
1
2021
1
1
2022
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
78
78
Fluid/Blood Leak
51
51
Device Contamination with Chemical or Other Material
16
16
Particulates
14
14
Device Operates Differently Than Expected
11
11
Crack
6
6
Other (for use when an appropriate device code cannot be identified)
5
5
Break
4
4
Occlusion Within Device
4
4
Out-Of-Box Failure
3
3
Infusion or Flow Problem
3
3
Fracture
2
2
Pressure Problem
2
2
Device Damaged Prior to Use
2
2
Filtration Problem
2
2
Complete Blockage
2
2
Improper Flow or Infusion
2
2
Partial Blockage
1
1
Contamination of Device Ingredient or Reagent
1
1
Free or Unrestricted Flow
1
1
Failure to Prime
1
1
Increase in Pressure
1
1
Component(s), broken
1
1
Coagulation in Device or Device Ingredient
1
1
Connection Problem
1
1
Noise, Audible
1
1
Contamination /Decontamination Problem
1
1
Contamination
1
1
Device Inoperable
1
1
Mechanical Problem
1
1
Restricted Flow rate
1
1
Insufficient Information
1
1
Difficult to Fold, Unfold or Collapse
1
1
Device Expiration Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Use of Device Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Handling Problem
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
65
65
No Patient Involvement
63
63
No Consequences Or Impact To Patient
14
14
No Information
12
12
No Clinical Signs, Symptoms or Conditions
8
8
No Patient involvement
5
5
Blood Loss
3
3
Thrombus
3
3
Low Oxygen Saturation
2
2
Seizures
1
1
Brain Injury
1
1
Rupture
1
1
Hyperglycemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medtronic Inc. Cardiac Rhythm Disease Management
II
Aug-14-2013
2
Medtronic Perfusion Systems
II
Dec-17-2019
3
Terumo Cardiovascular Systems Corporation
II
Sep-20-2013
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