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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
2017 131 131
2018 134 134
2019 82 82
2020 45 45
2021 41 41
2022 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 83 83
Leak/Splash 48 48
Device Operates Differently Than Expected 48 48
Disconnection 37 37
Noise, Audible 22 22
Defective Component 20 20
Crack 19 19
Pressure Problem 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Break 13 13
Obstruction of Flow 12 12
Misassembled 11 11
Device Displays Incorrect Message 11 11
Increase in Pressure 10 10
Insufficient Flow or Under Infusion 9 9
Detachment Of Device Component 9 9
No Flow 8 8
Improper Flow or Infusion 7 7
Infusion or Flow Problem 6 6
Misassembled During Installation 6 6
Complete Blockage 6 6
Air Leak 6 6
Loose or Intermittent Connection 6 6
Material Fragmentation 5 5
Material Separation 5 5
Component Missing 5 5
Improper or Incorrect Procedure or Method 5 5
Pumping Problem 5 5
Packaging Problem 5 5
Output Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Connection Problem 4 4
Device Dislodged or Dislocated 4 4
Gas Leak 4 4
Insufficient Information 4 4
Defective Device 4 4
Failure to Prime 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Occlusion Within Device 4 4
Hole In Material 4 4
Kinked 4 4
Mechanical Problem 4 4
Restricted Flow rate 4 4
Coagulation in Device or Device Ingredient 4 4
Material Discolored 4 4
Fracture 3 3
No Display/Image 3 3
Pumping Stopped 3 3
Material Puncture/Hole 3 3
Device Damaged Prior to Use 3 3
Decrease in Pressure 3 3
Patient Device Interaction Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Material Integrity Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Filtration Problem 2 2
Improper Device Output 2 2
Chemical Problem 2 2
Communication or Transmission Problem 2 2
Device Packaging Compromised 2 2
Component Misassembled 2 2
Appropriate Term/Code Not Available 2 2
Air/Gas in Device 2 2
Device Inoperable 2 2
Device Contamination with Body Fluid 2 2
Unable to Obtain Readings 2 2
Particulates 2 2
Moisture Damage 2 2
Inaccurate Flow Rate 2 2
Incorrect Measurement 2 2
Gas Output Problem 2 2
Partial Blockage 2 2
Decoupling 1 1
Collapse 1 1
Contamination 1 1
No Audible Alarm 1 1
Bent 1 1
Backflow 1 1
Clumping in Device or Device Ingredient 1 1
Burst Container or Vessel 1 1
Circuit Failure 1 1
Imprecision 1 1
Display or Visual Feedback Problem 1 1
False Reading From Device Non-Compliance 1 1
Unintended Ejection 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Loss of Power 1 1
No Device Output 1 1
Difficult to Remove 1 1
Failure to Sense 1 1
Product Quality Problem 1 1
Cut In Material 1 1
Out-Of-Box Failure 1 1
Material Perforation 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 163 163
No Consequences Or Impact To Patient 95 95
No Clinical Signs, Symptoms or Conditions 95 95
No Patient Involvement 61 61
Death 28 28
Hemorrhage/Bleeding 19 19
No Information 13 13
Low Oxygen Saturation 10 10
Blood Loss 7 7
No Code Available 4 4
Hypoxia 4 4
Hemolysis 4 4
Air Embolism 3 3
Bradycardia 3 3
Ischemia 3 3
Injury 3 3
Insufficient Information 3 3
Hypovolemia 2 2
Thrombosis 2 2
Low Blood Pressure/ Hypotension 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Pulmonary Embolism 2 2
Exsanguination 2 2
Hypothermia 1 1
Unspecified Infection 1 1
Pneumonia 1 1
Renal Failure 1 1
Sepsis 1 1
Transient Ischemic Attack 1 1
Brain Injury 1 1
Complaint, Ill-Defined 1 1
Coma 1 1
Thrombosis/Thrombus 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Sudden Cardiac Death 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 Datascope Corporation II Mar-23-2017
5 LivaNova USA III Feb-21-2018
6 LivaNova USA Inc. III Feb-27-2020
7 Maquet II Dec-20-2017
8 Sorin Group USA, Inc. II Jul-29-2017
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