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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
MDR Year
MDR Reports
MDR Events
2019
76
76
2020
53
53
2021
55
55
2022
48
48
2023
46
46
2024
298
298
Device Problems
MDRs with this Device Problem
Events in those MDRs
Leak/Splash
233
233
Human-Device Interface Problem
123
123
Loose or Intermittent Connection
68
68
Air/Gas in Device
53
53
Fluid/Blood Leak
19
19
Improper or Incorrect Procedure or Method
19
19
Display or Visual Feedback Problem
17
17
Physical Resistance/Sticking
10
10
Material Deformation
7
7
Gas/Air Leak
7
7
Fitting Problem
7
7
Defective Device
6
6
Inflation Problem
6
6
Failure to Cycle
6
6
Break
6
6
Device-Device Incompatibility
5
5
Difficult to Advance
5
5
Device Contamination with Chemical or Other Material
4
4
Crack
4
4
Deflation Problem
3
3
Difficult to Insert
3
3
Contamination /Decontamination Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Unstable
3
3
Product Quality Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
No Apparent Adverse Event
2
2
Noise, Audible
2
2
Detachment of Device or Device Component
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Split, Cut or Torn
2
2
Unsealed Device Packaging
2
2
Device Difficult to Setup or Prepare
2
2
Material Puncture/Hole
2
2
Difficult to Remove
2
2
Fracture
2
2
Mechanical Problem
2
2
Delivered as Unsterile Product
1
1
Flushing Problem
1
1
Backflow
1
1
Contamination
1
1
Corroded
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Material Separation
1
1
Device Slipped
1
1
Unable to Obtain Readings
1
1
Use of Device Problem
1
1
Device Contamination with Body Fluid
1
1
Separation Failure
1
1
Connection Problem
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
412
412
No Consequences Or Impact To Patient
60
60
Blood Loss
42
42
Insufficient Information
17
17
No Known Impact Or Consequence To Patient
14
14
Air Embolism
14
14
No Patient Involvement
6
6
Injury
5
5
Low Blood Pressure/ Hypotension
5
5
No Information
5
5
Hemorrhage/Bleeding
4
4
Not Applicable
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Overdose
1
1
Arrhythmia
1
1
Death
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 Inc
II
Sep-24-2021
5
Merit Medical Systems, Inc.
II
Apr-11-2022
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