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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Product CodeDTL
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 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 172 172
Loose or Intermittent Connection 58 58
Human-Device Interface Problem 28 28
Fluid/Blood Leak 19 19
Display or Visual Feedback Problem 17 17
Air/Gas in Device 10 10
Physical Resistance/Sticking 9 9
Improper or Incorrect Procedure or Method 7 7
Defective Device 6 6
Inflation Problem 6 6
Failure to Cycle 6 6
Break 6 6
Material Deformation 6 6
Gas/Air Leak 6 6
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
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
Unstable 2 2
Fracture 2 2
Mechanical Problem 2 2
Delivered as Unsterile Product 1 1
Flushing Problem 1 1
Backflow 1 1
Corroded 1 1
Use of Device Problem 1 1
Fitting Problem 1 1
Device Contamination with Body Fluid 1 1
Separation Failure 1 1
Connection Problem 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
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 196 196
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 7 7
No Patient Involvement 6 6
Injury 5 5
No Information 5 5
Hemorrhage/Bleeding 4 4
Low Blood Pressure/ Hypotension 3 3
Overdose 1 1
Arrhythmia 1 1
Death 1 1
Not Applicable 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 Inc II Sep-24-2021
5 Merit Medical Systems, Inc. II Apr-11-2022
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