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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 417 417

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 323 323
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 78 78
Air/Gas in Device 57 57
Fluid/Blood Leak 25 25
Improper or Incorrect Procedure or Method 19 19
Display or Visual Feedback Problem 17 17
Physical Resistance/Sticking 11 11
Fitting Problem 7 7
Material Deformation 7 7
Gas/Air Leak 7 7
Break 6 6
Failure to Cycle 6 6
Defective Device 6 6
Inflation Problem 6 6
Device-Device Incompatibility 5 5
Difficult to Advance 5 5
Device Contamination with Chemical or Other Material 4 4
Tear, Rip or Hole in Device Packaging 4 4
Product Quality Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Contamination /Decontamination Problem 4 4
Crack 4 4
Difficult to Insert 3 3
Deflation Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unsealed Device Packaging 3 3
Unstable 3 3
Device Difficult to Setup or Prepare 2 2
Difficult to Remove 2 2
Detachment of Device or Device Component 2 2
Material Puncture/Hole 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Mechanical Problem 2 2
Material Split, Cut or Torn 2 2
Noise, Audible 2 2
Patient Device Interaction Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unable to Obtain Readings 1 1
Backflow 1 1
Use of Device Problem 1 1
Contamination 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Separation Failure 1 1
Flushing Problem 1 1
Connection Problem 1 1
Device Contamination with Body Fluid 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 527 527
No Consequences Or Impact To Patient 60 60
Blood Loss 42 42
Air Embolism 18 18
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 14 14
Hemorrhage/Bleeding 10 10
No Patient Involvement 6 6
No Information 5 5
Injury 5 5
Low Blood Pressure/ Hypotension 3 3
Non specific EKG/ECG Changes 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Arrhythmia 1 1
Not Applicable 1 1
Overdose 1 1
Ventricular Fibrillation 1 1
Myocardial Infarction 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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