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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, oximeter, fiber-optic
Product CodeDQE
Regulation Number 870.1230
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 68 68
2017 47 47
2018 38 38
2019 63 63
2020 39 39
2021 39 39
2022 57 57
2023 52 52
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 108 108
Material Rupture 69 69
Incorrect Measurement 38 38
Leak/Splash 35 35
Adverse Event Without Identified Device or Use Problem 24 24
Fluid/Blood Leak 18 18
Appropriate Term/Code Not Available 13 13
Deflation Problem 12 12
Difficult to Insert 12 12
Material Separation 11 11
Material Split, Cut or Torn 11 11
Inflation Problem 11 11
Output Problem 9 9
Break 9 9
Unable to Obtain Readings 8 8
Kinked 7 7
Material Fragmentation 7 7
Device Contamination with Chemical or Other Material 7 7
Detachment of Device or Device Component 6 6
Positioning Problem 5 5
Difficult to Remove 5 5
Device Operates Differently Than Expected 4 4
Physical Resistance/Sticking 4 4
Detachment Of Device Component 4 4
Difficult to Advance 3 3
Malposition of Device 3 3
Insufficient Flow or Under Infusion 2 2
Device Alarm System 2 2
Display or Visual Feedback Problem 2 2
Crack 2 2
Temperature Problem 2 2
No Device Output 2 2
Defective Device 2 2
Microbial Contamination of Device 2 2
Insufficient Information 2 2
Unintended Movement 2 2
Knotted 2 2
Burst Container or Vessel 2 2
Material Twisted/Bent 2 2
Material Integrity Problem 2 2
Low Readings 2 2
Failure to Advance 2 2
Increase in Pressure 2 2
Device Displays Incorrect Message 2 2
High Test Results 2 2
Contamination /Decontamination Problem 2 2
Backflow 1 1
Output below Specifications 1 1
Difficult or Delayed Positioning 1 1
Component Misassembled 1 1
Material Frayed 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Display/Image 1 1
Deformation Due to Compressive Stress 1 1
Obstruction of Flow 1 1
Material Puncture/Hole 1 1
Retraction Problem 1 1
Component Missing 1 1
Looping 1 1
Device Dislodged or Dislocated 1 1
Activation, Positioning or Separation Problem 1 1
Device Inoperable 1 1
Inaccurate Flow Rate 1 1
Improper or Incorrect Procedure or Method 1 1
Unstable 1 1
Gas/Air Leak 1 1
Infusion or Flow Problem 1 1
False Reading From Device Non-Compliance 1 1
Human-Device Interface Problem 1 1
Physical Resistance 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Zero 1 1
No Pressure 1 1
Peeled/Delaminated 1 1
Poor Quality Image 1 1
Hole In Material 1 1
Positioning Failure 1 1
Protective Measures Problem 1 1
Failure to Deflate 1 1
Overheating of Device 1 1
Torn Material 1 1
Calibration Error 1 1
Pacing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 189 189
No Clinical Signs, Symptoms or Conditions 119 119
No Known Impact Or Consequence To Patient 72 72
Hemorrhage/Bleeding 10 10
No Patient Involvement 8 8
Insufficient Information 8 8
No Code Available 7 7
No Information 5 5
Blood Loss 5 5
Cardiac Perforation 5 5
Hypersensitivity/Allergic reaction 4 4
Perforation 4 4
Foreign Body In Patient 4 4
Shaking/Tremors 3 3
Low Blood Pressure/ Hypotension 3 3
Unspecified Infection 3 4
Congenital Defect/Deformity 3 3
Hemothorax 2 2
Fever 2 2
Hematoma 2 2
Injury 2 2
Perforation of Vessels 2 2
Chills 2 2
Respiratory Distress 2 2
Thrombus 2 2
Patient Problem/Medical Problem 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ectopic Heartbeat 1 1
Alteration In Body Temperature 1 1
Device Embedded In Tissue or Plaque 1 1
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Thrombosis 1 1
Pneumonia 1 1
Pneumothorax 1 1
High Blood Pressure/ Hypertension 1 1
Stenosis 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
Hemoptysis 1 1
Infiltration into Tissue 1 1
Mitral Valve Stenosis 1 1
Necrosis 1 1
Death 1 1
Dyspnea 1 1
Embolism 1 1
Encephalopathy 1 1
Angina 1 1
Aortic Insufficiency 1 1
Aortic Valve Stenosis 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Aug-12-2021
2 Edwards Lifesciences, LLC II Jul-10-2020
3 ICU Medical, Inc. II May-14-2020
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