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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
Product CodeDWE
Regulation Number 870.4390
Device Class 2

MDR Year MDR Reports MDR Events
2018 134 134
2019 82 82
2020 45 45
2021 41 41
2022 124 124

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 96 96
Disconnection 37 37
Leak/Splash 33 33
Device Operates Differently Than Expected 22 22
Defective Component 20 20
Obstruction of Flow 20 20
Noise, Audible 20 20
Crack 17 17
Break 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Material Deformation 11 11
Pressure Problem 11 11
Misassembled 10 10
Material Separation 10 10
Increase in Pressure 9 9
Misassembled During Installation 9 9
Insufficient Flow or Under Infusion 8 8
Mechanical Problem 8 8
Material Puncture/Hole 7 7
Improper Flow or Infusion 7 7
Air/Gas in Device 6 6
Packaging Problem 6 6
Pumping Problem 5 5
No Flow 5 5
Infusion or Flow Problem 5 5
Component Missing 5 5
Material Fragmentation 5 5
Loose or Intermittent Connection 4 4
Restricted Flow rate 4 4
Material Discolored 4 4
Coagulation in Device or Device Ingredient 4 4
Detachment Of Device Component 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Failure to Prime 4 4
Defective Device 3 3
Device Displays Incorrect Message 3 3
Detachment of Device or Device Component 3 3
Improper or Incorrect Procedure or Method 3 3
Gas/Air Leak 3 3
Output Problem 3 3
Patient Device Interaction Problem 3 3
Component Misassembled 3 3
Therapeutic or Diagnostic Output Failure 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Chemical Problem 2 2
Connection Problem 2 2
Device Dislodged or Dislocated 2 2
Pumping Stopped 2 2
Complete Blockage 2 2
Air Leak 2 2
Particulates 2 2
Fracture 2 2
Inaccurate Flow Rate 1 1
Incorrect Measurement 1 1
Gas Output Problem 1 1
Loss of Power 1 1
Decrease in Pressure 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Backflow 1 1
Partial Blockage 1 1
Circuit Failure 1 1
Clumping in Device or Device Ingredient 1 1
Collapse 1 1
Contamination 1 1
Decoupling 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Unintended Ejection 1 1
Material Perforation 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Sense 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Tidal Volume Fluctuations 1 1
Filtration Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Device Packaging Compromised 1 1
Device Sensing Problem 1 1
Device Markings/Labelling Problem 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Separation Problem 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Medical Gas Supply Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
No Known Impact Or Consequence To Patient 100 100
No Consequences Or Impact To Patient 68 68
No Patient Involvement 49 49
Hemorrhage/Bleeding 34 34
Death 21 21
Low Oxygen Saturation 9 9
Blood Loss 7 7
Hypovolemia 6 6
Hemolysis 4 4
Hypoxia 4 4
Insufficient Information 4 4
Ischemia 3 3
No Information 3 3
No Code Available 3 3
Thrombosis 2 2
Injury 2 2
Unspecified Infection 2 2
Stroke/CVA 2 2
Exsanguination 2 2
Bradycardia 2 2
Cardiac Arrest 1 1
Adhesion(s) 1 1
Air Embolism 1 1
Fistula 1 1
Inflammation 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Internal Organ Perforation 1 1
Pain 1 1
Pneumonia 1 1
Abdominal Distention 1 1
Pericardial Effusion 1 1
Thrombosis/Thrombus 1 1
Unspecified Tissue Injury 1 1
Complaint, Ill-Defined 1 1
Hernia 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Cardiac Perforation 1 1
Vascular System (Circulation), Impaired 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Datascope Corporation II Oct-11-2018
2 Datascope Corporation III Jun-06-2018
3 Datascope Corporation II May-08-2018
4 LivaNova USA III Feb-21-2018
5 LivaNova USA Inc. III Feb-27-2020
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