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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tubing, pump, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass pump tubing.
Product CodeDWE
Regulation Number 870.4390
Device Class 2

MDR Year MDR Reports MDR Events
2016 151 151
2017 131 131
2018 134 134
2019 83 83
2020 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 73 73
Leak/Splash 60 60
Fluid Leak 59 59
Crack 22 22
Noise, Audible 21 21
Disconnection 20 20
Defective Component 19 19
Break 17 17
Device Displays Incorrect Message 16 16
Pressure Problem 16 16
Adverse Event Without Identified Device or Use Problem 14 14
Improper Flow or Infusion 14 14
No Flow 13 13
Increase in Pressure 13 13
Air Leak 11 11
Tube 11 11
Failure to Prime 11 11
Insufficient Flow or Under Infusion 10 10
Detachment Of Device Component 10 10
Port 9 9
Loose or Intermittent Connection 9 9
Occlusion Within Device 9 9
Infusion or Flow Problem 9 9
Insufficient Information 9 9
Misassembled 8 8
Improper or Incorrect Procedure or Method 8 8
Kinked 7 7
Restricted Flow rate 7 7
Material Discolored 6 6
Connection Problem 6 6
Gas Leak 6 6
Complete Blockage 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Material Fragmentation 5 5
Cap 5 5
Pumping Problem 5 5
Defective Device 5 5
Obstruction of Flow 5 5
Device Inoperable 5 5
Connector 5 5
Coagulation in Device or Device Ingredient 4 4
Sensor 4 4
Device Damaged Prior to Use 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Device Contamination with Chemical or Other Material 4 4
Device Dislodged or Dislocated 4 4
No Display/Image 4 4
Pumping Stopped 4 4
Hole In Material 4 4
Incorrect Measurement 3 3
Nonstandard Device 3 3
Display or Visual Feedback Problem 3 3
Luer Valve 3 3
Cable, Electrical 3 3
Filter 3 3
Probe 3 3
Output Problem 3 3
Torn Material 3 3
Patient Device Interaction Problem 3 3
Improper Device Output 3 3
Decrease in Pressure 3 3
Fiber 3 3
Partial Blockage 3 3
Jaw 2 2
Contamination 2 2
Lock 2 2
Valve(s) 2 2
Inaccurate Flow Rate 2 2
Moisture Damage 2 2
Unable to Obtain Readings 2 2
Malposition of Device 2 2
Device Contamination with Body Fluid 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Incorrect Device Or Component Shipped 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Filtration Problem 2 2
Stopcock 2 2
Incorrect Or Inadequate Test Results 2 2
Communication or Transmission Problem 2 2
Detachment of Device or Device Component 2 2
Device Packaging Compromised 2 2
Device Slipped 2 2
Difficult to Remove 2 2
Gas Output Problem 2 2
Particulates 2 2
Loss of Power 1 1
Failure to Sense 1 1
Material Separation 1 1
No Device Output 1 1
Collapse 1 1
Fracture 1 1
Reservoir 1 1
Display 1 1
Manifold 1 1
False Device Output 1 1
False Reading From Device Non-Compliance 1 1
Unintended Ejection 1 1
No Audible Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 256 256
No Consequences Or Impact To Patient 100 100
No Patient Involvement 70 70
Death 37 37
No Information 22 22
Low Oxygen Saturation 14 14
Blood Loss 9 9
Hemolysis 8 8
Hemorrhage/Bleeding 6 6
No Code Available 5 5
Air Embolism 4 4
Ischemia 3 3
Thrombus 3 3
Injury 3 3
Bradycardia 3 3
Cardiac Arrest 3 3
Unspecified Infection 3 3
Stroke/CVA 2 2
Hypoxia 2 2
Brain Injury 2 2
Pulmonary Embolism 2 2
Thrombosis 2 2
Exsanguination 2 2
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Renal Failure 1 1
Sepsis 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 1 1
Hypovolemia 1 1
Toxicity 1 1
Coma 1 1
Transient Ischemic Attack 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Complaint, Ill-Defined 1 1
Vascular System (Circulation), Impaired 1 1
Patient Problem/Medical Problem 1 1
Myocardial Infarction 1 1
Pneumonia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Inc. (Navilyst Medical Inc.) II May-20-2016
2 Datascope Corporation II Oct-11-2018
3 Datascope Corporation III Jun-06-2018
4 Datascope Corporation II May-08-2018
5 Datascope Corporation II Mar-23-2017
6 Datascope Corporation II Jun-15-2016
7 LivaNova USA III Feb-21-2018
8 LivaNova USA Inc. III Feb-27-2020
9 Maquet II Dec-20-2017
10 Sorin Group USA, Inc. II Jul-29-2017
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