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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, blood, cardiopulmonary bypass, roller type
Regulation Description Roller-type cardiopulmonary bypass blood pump.
Product CodeDWB
Regulation Number 870.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 318 318
2017 361 361
2018 258 258
2019 155 155
2020 79 79
2021 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 261 261
No Display/Image 255 255
Pumping Stopped 194 194
Pumping Problem 91 91
Appropriate Term/Code Not Available 60 60
Device Operational Issue 53 53
Failure to Pump 45 45
Display or Visual Feedback Problem 45 45
Device Operates Differently Than Expected 44 44
Failure to Power Up 26 26
Mechanical Jam 19 19
Break 17 17
Mechanical Problem 16 16
Fracture 15 15
Failure to Auto Stop 15 15
Detachment Of Device Component 15 15
Output Problem 14 14
Device Stops Intermittently 13 13
Loss of Power 11 11
Communication or Transmission Problem 9 9
Erratic or Intermittent Display 9 9
Image Display Error/Artifact 8 8
Connection Problem 7 7
Unexpected Shutdown 7 7
Device Slipped 6 6
Device Alarm System 6 6
False Alarm 6 6
Decreased Pump Speed 5 5
Detachment of Device or Device Component 5 5
Calibration Problem 4 4
Fluid Leak 4 4
Device Inoperable 4 4
Positioning Problem 4 4
Power Problem 4 4
Insufficient Flow or Under Infusion 3 3
Device Markings/Labelling Problem 3 3
Alarm Not Visible 3 3
Incorrect Measurement 3 3
No Audible Alarm 3 3
Crack 3 3
Component Missing 3 3
Activation, Positioning or SeparationProblem 3 3
Noise, Audible 3 3
Infusion or Flow Problem 3 3
Protective Measures Problem 3 3
Physical Property Issue 2 2
No Flow 2 2
Human Factors Issue 2 2
Device Issue 2 2
Use of Device Problem 2 2
Increased Pump Speed 2 2
Overheating of Device 2 2
Thermal Decomposition of Device 2 2
Leak/Splash 2 2
Electrical /Electronic Property Problem 2 2
Decrease in Pressure 2 2
Display Difficult to Read 2 2
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Intermittent Communication Failure 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Inaccurate Flow Rate 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 1 1
Defective Alarm 1 1
Failure to Conduct 1 1
Contamination 1 1
Intermittent Continuity 1 1
Device Sensing Problem 1 1
Improper Device Output 1 1
Inappropriate or Unexpected Reset 1 1
Material Deformation 1 1
Material Distortion 1 1
Material Integrity Problem 1 1
Device Contamination with Body Fluid 1 1
Intermittent Infusion 1 1
Difficult or Delayed Activation 1 1
Unstable 1 1
Volume Accuracy Problem 1 1
Difficult To Position 1 1
Pre Or Post-Pumping Problem 1 1
Low Audible Alarm 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Charred 1 1
Complete Blockage 1 1
Use of Incorrect Control Settings 1 1
Smoking 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Too Rigid or Stiff 1 1
Physical Resistance 1 1
Improper Flow or Infusion 1 1
Naturally Worn 1 1
Failure to Shut Off 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Operating System Becomes Nonfunctional 1 1
Temperature Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 573 573
No Patient Involvement 566 566
No Clinical Signs, Symptoms or Conditions 33 33
No Known Impact Or Consequence To Patient 22 22
No Information 12 12
Death 4 4
Air Embolism 2 2
Loss of consciousness 1 1
Hemolysis 1 1
Blood Loss 1 1
Cardiac Arrest 1 1

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