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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
2019 82 82
2020 45 45
2021 41 41
2022 123 123
2023 287 287
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 288 288
Material Puncture/Hole 37 37
Material Separation 36 36
Disconnection 36 36
Material Deformation 30 30
Obstruction of Flow 27 27
Leak/Splash 25 25
Crack 24 24
Air/Gas in Device 19 19
Noise, Audible 14 14
Misassembled During Installation 13 13
Misassembled 12 12
Mechanical Problem 11 11
Break 9 9
Tear, Rip or Hole in Device Packaging 9 9
Pressure Problem 9 9
Adverse Event Without Identified Device or Use Problem 6 6
Component Missing 6 6
Insufficient Flow or Under Infusion 6 6
Increase in Pressure 6 6
Defective Component 5 5
No Flow 5 5
Packaging Problem 5 5
Material Split, Cut or Torn 5 5
Infusion or Flow Problem 5 5
Gas/Air Leak 4 4
Improper Flow or Infusion 4 4
Detachment of Device or Device Component 4 4
Component Misassembled 4 4
Coagulation in Device or Device Ingredient 4 4
Decoupling 3 3
Loose or Intermittent Connection 3 3
Difficult to Remove 3 3
Patient Device Interaction Problem 3 3
Output Problem 3 3
Pumping Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Mechanical Jam 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Chemical Problem 2 2
Connection Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Particulates 2 2
Contamination 2 2
Fracture 2 2
Gas Output Problem 1 1
Entrapment of Device 1 1
Inaccurate Flow Rate 1 1
Device Difficult to Setup or Prepare 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Incorrect Measurement 1 1
Loss of or Failure to Bond 1 1
Failure to Sense 1 1
Device Damaged Prior to Use 1 1
Pumping Stopped 1 1
Product Quality Problem 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Tidal Volume Fluctuations 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1
Separation Problem 1 1
Deformation Due to Compressive Stress 1 1
Filtration Problem 1 1
Free or Unrestricted Flow 1 1
Device Sensing Problem 1 1
Medical Gas Supply Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 409 409
Hemorrhage/Bleeding 68 68
No Known Impact Or Consequence To Patient 48 48
No Consequences Or Impact To Patient 41 41
No Patient Involvement 14 14
Death 12 12
Low Oxygen Saturation 9 9
Hypovolemia 6 6
Insufficient Information 5 5
Blood Loss 4 4
Hemolysis 3 3
Ischemia 3 3
Bradycardia 2 2
Stroke/CVA 2 2
Hypoxia 2 2
Exsanguination 2 2
Injury 2 2
Unspecified Infection 1 1
Hypothermia 1 1
Air Embolism 1 1
Respiratory Acidosis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Low Blood Pressure/ Hypotension 1 1
Patient Problem/Medical Problem 1 1
Internal Organ Perforation 1 1
Thrombosis/Thrombus 1 1
Thrombosis 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericardial Effusion 1 1
Cardiac Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova USA Inc. III Feb-27-2020
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