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TPLC
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Device
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product Code
DTL
Regulation Number
870.4290
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
76
76
2020
53
53
2021
55
55
2022
48
48
2023
46
46
2024
453
453
2025
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
367
367
Human-Device Interface Problem
123
123
Loose or Intermittent Connection
82
82
Air/Gas in Device
57
57
Fluid/Blood Leak
28
28
Physical Resistance/Sticking
21
21
Improper or Incorrect Procedure or Method
19
19
Display or Visual Feedback Problem
17
17
Gas/Air Leak
7
7
Defective Device
7
7
Material Deformation
7
7
Fitting Problem
7
7
Break
6
6
Inflation Problem
6
6
Failure to Cycle
6
6
Difficult to Advance
5
5
Device-Device Incompatibility
5
5
Tear, Rip or Hole in Device Packaging
5
5
Crack
4
4
Product Quality Problem
4
4
Contamination /Decontamination Problem
4
4
Device Contamination with Chemical or Other Material
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Unsealed Device Packaging
3
3
Deflation Problem
3
3
Unstable
3
3
Difficult to Insert
3
3
Difficult to Remove
3
3
No Apparent Adverse Event
3
3
Therapeutic or Diagnostic Output Failure
3
3
Contamination
2
2
Material Split, Cut or Torn
2
2
Material Separation
2
2
Material Puncture/Hole
2
2
Fracture
2
2
Device Difficult to Setup or Prepare
2
2
Noise, Audible
2
2
Detachment of Device or Device Component
2
2
Mechanical Problem
2
2
Device Contamination with Body Fluid
1
1
Backflow
1
1
Patient Device Interaction Problem
1
1
Device Slipped
1
1
Corroded
1
1
Connection Problem
1
1
Separation Failure
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Delivered as Unsterile Product
1
1
Use of Device Problem
1
1
Unable to Obtain Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
580
580
No Consequences Or Impact To Patient
60
60
Blood Loss
42
42
Air Embolism
19
19
Insufficient Information
17
17
No Known Impact Or Consequence To Patient
14
14
Hemorrhage/Bleeding
10
10
No Patient Involvement
6
6
Injury
5
5
No Information
5
5
Low Blood Pressure/ Hypotension
3
3
Ventricular Fibrillation
2
2
Non specific EKG/ECG Changes
2
2
Myocardial Infarction
1
1
Overdose
1
1
Not Applicable
1
1
Arrhythmia
1
1
Death
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
May-16-2023
2
LivaNova USA Inc.
III
Jul-17-2020
3
LivaNova USA Inc.
II
Jun-26-2020
4
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
5
Medline Industries Inc
II
Sep-24-2021
6
Merit Medical Systems, Inc.
II
Apr-11-2022
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