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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
Regulation Description Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
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 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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