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TPLC
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Device
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Product Code
DTL
Regulation Number
870.4290
Device Class
2
Premarket Reviews
Manufacturer
Decision
COEUR, INC.
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC.
SUBSTANTIALLY EQUIVALENT
1
GALT MEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
1
JILIN CORONADO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
3
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
3
NAVILYST MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
SYNEXMED(SHENZHEN)COMPANY LIMITED
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS ZERUSA LTD.
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
ZERUSA LIMITED
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
80
80
2015
89
89
2016
67
67
2017
106
106
2018
84
84
2019
76
76
2020
53
53
2021
55
55
2022
48
48
2023
46
46
2024
329
329
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
447
447
Human-Device Interface Problem
123
123
Loose or Intermittent Connection
78
78
Air/Gas in Device
56
56
Fluid/Blood Leak
31
31
Hole In Material
29
29
Tear, Rip or Hole in Device Packaging
27
27
Improper or Incorrect Procedure or Method
20
20
Unable to Obtain Readings
19
19
Infusion or Flow Problem
18
18
Display or Visual Feedback Problem
17
17
Device Contamination with Chemical or Other Material
16
16
Air Leak
16
16
Crack
15
15
Break
13
13
Physical Resistance/Sticking
11
11
Detachment Of Device Component
11
11
Suction Problem
11
11
Device Markings/Labelling Problem
10
10
Defective Device
9
9
Adverse Event Without Identified Device or Use Problem
8
8
Device Operates Differently Than Expected
8
8
Fitting Problem
7
7
Physical Resistance
7
7
Material Deformation
7
7
Inflation Problem
7
7
Gas/Air Leak
7
7
Failure to Cycle
6
6
Delivered as Unsterile Product
6
6
Improper Device Output
6
6
No Flow
6
6
Material Integrity Problem
5
5
Difficult to Advance
5
5
Device Packaging Compromised
5
5
Difficult to Insert
5
5
Device-Device Incompatibility
5
5
Fracture
4
4
Deflation Problem
4
4
Difficult to Remove
4
4
Connection Problem
4
4
Use of Device Problem
4
4
Device Disinfection Or Sterilization Issue
4
4
Therapeutic or Diagnostic Output Failure
3
3
Unsealed Device Packaging
3
3
Contamination /Decontamination Problem
3
3
Mechanical Problem
3
3
Material Puncture/Hole
3
3
Improper Flow or Infusion
3
3
Unstable
3
3
No Apparent Adverse Event
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
437
437
No Consequences Or Impact To Patient
233
233
Blood Loss
115
115
No Known Impact Or Consequence To Patient
85
85
No Patient Involvement
62
62
Air Embolism
31
31
Not Applicable
24
24
No Information
18
18
Insufficient Information
17
17
Hemorrhage/Bleeding
10
10
Cardiac Arrest
9
9
Injury
6
6
Low Blood Pressure/ Hypotension
6
6
Non specific EKG/ECG Changes
2
2
Bradycardia
2
2
Embolism
2
2
ST Segment Elevation
2
2
Patient Problem/Medical Problem
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
Arrhythmia
1
1
Ventricular Tachycardia
1
1
Perforation
1
1
No Patient involvement
1
1
Obstruction/Occlusion
1
1
Overdose
1
1
Ventricular Fibrillation
1
1
Discomfort
1
1
Collapse
1
1
Myocardial Infarction
1
1
Respiratory Failure
1
1
Thrombus
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Vascular
II
Jul-12-2011
2
Boston Scientific Corporation
II
May-16-2023
3
Cook Inc.
II
May-09-2018
4
Dokitz NovoSci
II
Nov-06-2014
5
Edwards Lifesciences Llc
II
Dec-07-2010
6
LivaNova USA Inc.
III
Jul-17-2020
7
LivaNova USA Inc.
II
Jun-26-2020
8
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
9
Medline Industries Inc
II
Sep-24-2021
10
Medtronic Perfusion Systems
II
Jul-10-2017
11
Merit Medical Systems, Inc.
II
Apr-11-2022
12
Sorin Group USA, Inc.
II
Oct-25-2012
13
Terumo Cardiovascular Systems Corp
II
Jun-23-2015
14
Terumo Cardiovascular Systems Corporation
II
Jun-21-2018
15
Thomas Medical Products Inc
II
Feb-14-2011
16
Vascular Solutions, Inc.
I
Apr-07-2016
17
Vascular Solutions, Inc.
I
Mar-20-2013
18
Vascular Solutions, Inc.
II
Sep-17-2012
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