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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


Premarket Reviews
ManufacturerDecision
COEUR, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
JILIN CORONADO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNEXMED(SHENZHEN)COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS ZERUSA LTD.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZERUSA LIMITED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 80 80
2015 89 89
2016 67 67
2017 106 106
2018 84 84
2019 76 76
2020 53 53
2021 55 55
2022 48 48
2023 46 46
2024 329 329

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 447 447
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 78 78
Air/Gas in Device 56 56
Fluid/Blood Leak 31 31
Hole In Material 29 29
Tear, Rip or Hole in Device Packaging 27 27
Improper or Incorrect Procedure or Method 20 20
Unable to Obtain Readings 19 19
Infusion or Flow Problem 18 18
Display or Visual Feedback Problem 17 17
Air Leak 16 16
Device Contamination with Chemical or Other Material 16 16
Crack 15 15
Break 13 13
Physical Resistance/Sticking 11 11
Detachment Of Device Component 11 11
Suction Problem 11 11
Device Markings/Labelling Problem 10 10
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Device Operates Differently Than Expected 8 8
Material Deformation 7 7
Inflation Problem 7 7
Physical Resistance 7 7
Gas/Air Leak 7 7
Fitting Problem 7 7
Improper Device Output 6 6
No Flow 6 6
Delivered as Unsterile Product 6 6
Failure to Cycle 6 6
Device Packaging Compromised 5 5
Device-Device Incompatibility 5 5
Difficult to Insert 5 5
Difficult to Advance 5 5
Material Integrity Problem 5 5
Difficult to Remove 4 4
Use of Device Problem 4 4
Deflation Problem 4 4
Connection Problem 4 4
Fracture 4 4
Device Disinfection Or Sterilization Issue 4 4
Mechanical Problem 3 3
Unstable 3 3
Therapeutic or Diagnostic Output Failure 3 3
Unsealed Device Packaging 3 3
Product Quality Problem 3 3
Material Puncture/Hole 3 3
No Apparent Adverse Event 3 3
Detachment of Device or Device Component 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 437 437
No Consequences Or Impact To Patient 233 233
Blood Loss 115 115
No Known Impact Or Consequence To Patient 85 85
No Patient Involvement 62 62
Air Embolism 31 31
Not Applicable 24 24
No Information 18 18
Insufficient Information 17 17
Hemorrhage/Bleeding 10 10
Cardiac Arrest 9 9
Injury 6 6
Low Blood Pressure/ Hypotension 6 6
Non specific EKG/ECG Changes 2 2
Bradycardia 2 2
Embolism 2 2
ST Segment Elevation 2 2
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Arrhythmia 1 1
Ventricular Tachycardia 1 1
Perforation 1 1
No Patient involvement 1 1
Obstruction/Occlusion 1 1
Overdose 1 1
Ventricular Fibrillation 1 1
Discomfort 1 1
Collapse 1 1
Myocardial Infarction 1 1
Respiratory Failure 1 1
Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jul-12-2011
2 Boston Scientific Corporation II May-16-2023
3 Cook Inc. II May-09-2018
4 Dokitz NovoSci II Nov-06-2014
5 Edwards Lifesciences Llc II Dec-07-2010
6 LivaNova USA Inc. III Jul-17-2020
7 LivaNova USA Inc. II Jun-26-2020
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 Medline Industries Inc II Sep-24-2021
10 Medtronic Perfusion Systems II Jul-10-2017
11 Merit Medical Systems, Inc. II Apr-11-2022
12 Sorin Group USA, Inc. II Oct-25-2012
13 Terumo Cardiovascular Systems Corp II Jun-23-2015
14 Terumo Cardiovascular Systems Corporation II Jun-21-2018
15 Thomas Medical Products Inc II Feb-14-2011
16 Vascular Solutions, Inc. I Apr-07-2016
17 Vascular Solutions, Inc. I Mar-20-2013
18 Vascular Solutions, Inc. II Sep-17-2012
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