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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device catheter, cannula and tubing, vascular, cardiopulmonary bypass
Product CodeDWF
Regulation Number 870.4210
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOGARD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
KAPP SURGICAL INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 471 471
2024 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 178 178
Mechanical Problem 146 146
Fluid/Blood Leak 142 142
Material Puncture/Hole 140 140
Crack 133 133
Adverse Event Without Identified Device or Use Problem 133 133
Material Separation 92 92
Obstruction of Flow 54 54
Break 54 54
Detachment of Device or Device Component 46 46
Disconnection 42 42
Leak/Splash 40 40
Fracture 38 38
Insufficient Information 26 26
Material Twisted/Bent 24 24
Packaging Problem 23 23
Air/Gas in Device 21 21
Material Split, Cut or Torn 19 19
Loss of or Failure to Bond 18 18
Nonstandard Device 17 17
Migration 13 13
Gas/Air Leak 13 13
Misassembled During Installation 11 11
Difficult to Insert 11 11
Device Markings/Labelling Problem 10 10
Improper Flow or Infusion 9 9
Defective Component 9 9
Component Missing 8 8
Material Rupture 8 8
Increase in Pressure 7 7
Defective Device 7 7
Deformation Due to Compressive Stress 7 7
Contamination 7 7
Device Contamination with Chemical or Other Material 7 7
Infusion or Flow Problem 6 6
No Flow 6 6
Material Integrity Problem 6 6
Ejection Problem 6 6
Coagulation in Device or Device Ingredient 6 6
Loose or Intermittent Connection 6 6
Unsealed Device Packaging 5 5
Restricted Flow rate 5 5
Positioning Failure 5 5
Material Discolored 5 5
Malposition of Device 5 5
Improper or Incorrect Procedure or Method 5 5
Physical Resistance/Sticking 5 5
Appropriate Term/Code Not Available 5 5
Device Handling Problem 5 5
Positioning Problem 5 5
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Difficult to Remove 4 4
Contamination /Decontamination Problem 4 4
Partial Blockage 4 4
Inflation Problem 4 4
Delivered as Unsterile Product 4 4
Backflow 3 3
Burst Container or Vessel 3 3
Complete Blockage 3 3
Connection Problem 3 3
Use of Device Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Off-Label Use 3 3
Device Slipped 3 3
No Apparent Adverse Event 3 3
Free or Unrestricted Flow 3 3
Difficult to Advance 3 3
Material Too Soft/Flexible 3 3
Patient Device Interaction Problem 2 2
Separation Problem 2 2
Premature Separation 2 2
Device Dislodged or Dislocated 2 2
Explosion 2 2
Protective Measures Problem 2 2
Unraveled Material 2 2
Inadequacy of Device Shape and/or Size 2 2
Insufficient Flow or Under Infusion 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 2 2
Failure to Advance 2 2
Device Displays Incorrect Message 2 2
Collapse 2 2
Decoupling 2 2
Deflation Problem 2 2
Entrapment of Device 2 2
Particulates 2 2
Device Difficult to Setup or Prepare 2 2
Inaccurate Flow Rate 2 2
Material Fragmentation 2 2
Gel Leak 1 1
Incorrect Measurement 1 1
Melted 1 1
Misassembled 1 1
Material Erosion 1 1
Display or Visual Feedback Problem 1 1
Data Back-Up Problem 1 1
Activation, Positioning or Separation Problem 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 745 745
Hemorrhage/Bleeding 121 121
No Known Impact Or Consequence To Patient 111 111
No Consequences Or Impact To Patient 57 57
Blood Loss 36 36
Insufficient Information 34 34
Death 27 27
Cardiac Arrest 25 25
Perforation of Vessels 21 21
Exsanguination 18 18
Thrombosis/Thrombus 17 17
Hematoma 16 16
Low Blood Pressure/ Hypotension 15 15
Air Embolism 14 14
Ischemia 13 13
Cardiac Perforation 12 12
Cardiac Tamponade 11 11
No Patient Involvement 11 11
Device Embedded In Tissue or Plaque 10 10
Perforation 10 10
Vascular Dissection 9 9
Swelling/ Edema 8 8
Obstruction/Occlusion 8 8
Sepsis 7 7
Unspecified Infection 7 7
Hemolysis 6 6
Bradycardia 6 6
Hypovolemia 6 6
Respiratory Failure 6 6
Stroke/CVA 5 5
Pulmonary Embolism 5 5
Hypoxia 5 5
Foreign Body In Patient 5 5
No Code Available 4 4
Multiple Organ Failure 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Laceration(s) 4 4
Bacterial Infection 4 4
Decreased Respiratory Rate 4 4
Bronchopneumonia 4 4
Rupture 4 4
Brain Injury 4 4
Low Oxygen Saturation 3 3
Venipuncture 3 3
Pulmonary Edema 3 3
Pulmonary Hypertension 3 3
Unspecified Tissue Injury 2 2
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Asystole 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Thrombocytopenia 2 2
Embolism/Embolus 2 2
Pneumothorax 2 2
Aortic Dissection 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Airway Obstruction 2 2
Arrhythmia 2 2
Cardiopulmonary Arrest 2 2
Non specific EKG/ECG Changes 2 2
Endocarditis 2 2
Pain 2 2
Extravasation 2 2
Foreign Body Reaction 2 2
Intracranial Hemorrhage 1 1
Hyperbilirubinemia 1 1
High Blood Pressure/ Hypertension 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Neurological Deficit/Dysfunction 1 1
Failure of Implant 1 1
Dyspnea 1 1
Chest Pain 1 1
Atrial Flutter 1 1
Aneurysm 1 1
Myocardial Contusion 1 1
Vascular System (Circulation), Impaired 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Blurred Vision 1 1
Tingling 1 1
Pulmonary Dysfunction 1 1
Renal Failure 1 1
Scar Tissue 1 1
Septic Shock 1 1
Swelling 1 1
Tachycardia 1 1
Thrombosis 1 1
Tissue Damage 1 1
Ulceration 1 1
Ulcer 1 1
Hemolytic Anemia 1 1
Distress 1 1
Sedation 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc III Nov-29-2021
2 Cardiac Assist, Inc II Feb-07-2020
3 Edwards Lifesciences, LLC II Jan-10-2020
4 Edwards Lifesciences, LLC II Nov-18-2019
5 LivaNova USA II Jan-23-2019
6 LivaNova USA Inc. II Jun-26-2020
7 Maquet Cardiovascular, LLC II May-31-2019
8 Medtronic Perfusion Systems II May-10-2024
9 Medtronic Perfusion Systems II Mar-19-2024
10 Medtronic Perfusion Systems II Jan-12-2022
11 Medtronic Perfusion Systems II Oct-01-2021
12 Medtronic Perfusion Systems II Jun-16-2021
13 OriGen Biomedical, Inc. I Jun-04-2019
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