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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 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 309 309
Material Puncture/Hole 40 40
Disconnection 37 37
Material Separation 37 37
Material Deformation 33 33
Obstruction of Flow 32 32
Crack 28 28
Leak/Splash 26 26
Air/Gas in Device 21 21
Noise, Audible 14 14
Misassembled 14 14
Misassembled During Installation 13 13
Tear, Rip or Hole in Device Packaging 12 12
Mechanical Problem 11 11
Break 9 9
Pressure Problem 9 9
No Flow 7 7
Component Missing 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Increase in Pressure 6 6
Insufficient Flow or Under Infusion 6 6
Packaging Problem 5 5
Material Split, Cut or Torn 5 5
Defective Component 5 5
Infusion or Flow Problem 5 5
Gas/Air Leak 4 4
Coagulation in Device or Device Ingredient 4 4
Component Misassembled 4 4
Detachment of Device or Device Component 4 4
Improper Flow or Infusion 4 4
Output Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Loose or Intermittent Connection 3 3
Pumping Problem 3 3
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Decoupling 3 3
Contamination 2 2
Improper or Incorrect Procedure or Method 2 2
Fracture 2 2
Connection Problem 2 2
Chemical Problem 2 2
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Particulates 2 2
Mechanical Jam 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Defective Device 2 2
Pumping Stopped 1 1
Insufficient Information 1 1
Separation Problem 1 1
Filtration Problem 1 1
No Device Output 1 1
Device Slipped 1 1
Free or Unrestricted Flow 1 1
Entrapment of Device 1 1
Device Damaged Prior to Use 1 1
Physical Resistance/Sticking 1 1
Tidal Volume Fluctuations 1 1
Gas Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Difficult to Setup or Prepare 1 1
Deformation Due to Compressive Stress 1 1
Incorrect Measurement 1 1
Loss of or Failure to Bond 1 1
Delivered as Unsterile Product 1 1
Failure to Sense 1 1
Medical Gas Supply Problem 1 1
Device Sensing Problem 1 1
Product Quality Problem 1 1
Inaccurate Flow Rate 1 1
Material Integrity Problem 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 446 446
Hemorrhage/Bleeding 72 72
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
Air Embolism 2 2
Hypothermia 1 1
Unspecified Infection 1 1
Paralysis 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
Ischemia Stroke 1 1
Cardiac Perforation 1 1

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