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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
Material Separation 37 37
Disconnection 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
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
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
Output Problem 3 3
Patient Device Interaction 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 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
Injury 2 2
Exsanguination 2 2
Air Embolism 2 2
Bradycardia 2 2
Stroke/CVA 2 2
Hypoxia 2 2
Unspecified Infection 1 1
Low Blood Pressure/ Hypotension 1 1
Hypothermia 1 1
Respiratory Acidosis 1 1
Cardiac Perforation 1 1
Internal Organ Perforation 1 1
Paralysis 1 1
Thrombosis 1 1
Patient Problem/Medical Problem 1 1
Pericardial Effusion 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Heart Failure/Congestive Heart Failure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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