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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
  1.  K113845  TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE B ...
  2.  K122811  CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
  3.  K123448  AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE B ...
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 276 276

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 405 405
Human-Device Interface Problem 123 123
Loose or Intermittent Connection 76 76
Air/Gas in Device 51 51
Hole In Material 29 29
Fluid/Blood Leak 28 28
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 12 12
Detachment Of Device Component 11 11
Suction Problem 11 11
Device Markings/Labelling Problem 10 10
Physical Resistance/Sticking 10 10
Defective Device 9 9
Device Operates Differently Than Expected 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Gas/Air Leak 7 7
Physical Resistance 7 7
Fitting Problem 7 7
Inflation Problem 7 7
Failure to Cycle 6 6
Delivered as Unsterile Product 6 6
Improper Device Output 6 6
Material Deformation 6 6
No Flow 6 6
Material Integrity Problem 5 5
Device Packaging Compromised 5 5
Device-Device Incompatibility 5 5
Difficult to Advance 5 5
Difficult to Insert 5 5
Difficult to Remove 4 4
Fracture 4 4
Deflation Problem 4 4
Connection Problem 4 4
Device Disinfection Or Sterilization Issue 4 4
Use of Device Problem 4 4
Unstable 3 3
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Improper Flow or Infusion 3 3
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Mechanical Problem 3 3
Unsealed Device Packaging 3 3
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Pressure Problem 2 2
Suction Failure 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
Difficult To Position 2 2
Device Difficult to Setup or Prepare 2 2
Material Separation 2 2
Problem with Sterilization 2 2
Device Contaminated During Manufacture or Shipping 2 2
Insufficient Flow or Under Infusion 2 2
Component Missing 2 2
Device Contamination with Body Fluid 1 1
Other (for use when an appropriate device code cannot be identified) 1 1
Device Damaged Prior to Use 1 1
Failure to Zero 1 1
Implant Mobility NOS (Not otherwise specified) 1 1
Malfunction 1 1
Obstruction of Flow 1 1
Failure to Advance 1 1
Separation Failure 1 1
Mechanical Jam 1 1
Difficult to Open or Close 1 1
Filtration Problem 1 1
Device Inoperable 1 1
Device Slipped 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Off-Label Use 1 1
Kinked 1 1
Disconnection 1 1
Difficult to Flush 1 1
Flushing Problem 1 1
Excess Flow or Over-Infusion 1 1
Decoupling 1 1
Bent 1 1
Backflow 1 1
Contamination 1 1
Corroded 1 1
Patient Device Interaction Problem 1 1
Output Problem 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 392 392
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 30 30
Not Applicable 24 24
No Information 18 18
Insufficient Information 17 17
Cardiac Arrest 9 9
Injury 6 6
Hemorrhage/Bleeding 4 4
Low Blood Pressure/ Hypotension 4 4
Non specific EKG/ECG Changes 2 2
Embolism 2 2
ST Segment Elevation 2 2
Bradycardia 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Collapse 1 1
Obstruction/Occlusion 1 1
Respiratory Failure 1 1
No Patient involvement 1 1
Patient Problem/Medical Problem 1 1
Thrombus 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Discomfort 1 1
Myocardial Infarction 1 1
Overdose 1 1
Perforation 1 1
Death 1 1
Arrhythmia 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 Inc II Sep-24-2021
9 Medtronic Perfusion Systems II Jul-10-2017
10 Merit Medical Systems, Inc. II Apr-11-2022
11 Sorin Group USA, Inc. II Oct-25-2012
12 Terumo Cardiovascular Systems Corp II Jun-23-2015
13 Terumo Cardiovascular Systems Corporation II Jun-21-2018
14 Thomas Medical Products Inc II Feb-14-2011
15 Vascular Solutions, Inc. I Apr-07-2016
16 Vascular Solutions, Inc. I Mar-20-2013
17 Vascular Solutions, Inc. II Sep-17-2012
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