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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
  1.  K162843  Small (4) Roller Pump for the Terumo Advanced Perf ...

MDR Year MDR Reports MDR Events
2016 318 318
2017 361 361
2018 258 258
2019 155 155
2020 79 79
2021 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 261 261
No Display/Image 255 255
Pumping Stopped 195 195
Pumping Problem 96 96
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
Detachment Of Device Component 15 15
Failure to Auto Stop 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
Positioning Problem 4 4
Power Problem 4 4
Device Inoperable 4 4
Calibration Problem 4 4
Fluid Leak 4 4
Crack 3 3
No Audible Alarm 3 3
Alarm Not Visible 3 3
Activation, Positioning or SeparationProblem 3 3
Insufficient Flow or Under Infusion 3 3
Component Missing 3 3
Incorrect Measurement 3 3
Protective Measures Problem 3 3
Noise, Audible 3 3
Device Markings/Labelling Problem 3 3
Infusion or Flow Problem 3 3
No Flow 2 2
Human Factors Issue 2 2
Physical Property Issue 2 2
Increased Pump Speed 2 2
Decrease in Pressure 2 2
Use of Device Problem 2 2
Device Issue 2 2
Thermal Decomposition of Device 2 2
Display Difficult to Read 2 2
Electrical /Electronic Property Problem 2 2
Leak/Splash 2 2
Overheating of Device 2 2
Difficult To Position 1 1
Moisture Damage 1 1
Loose or Intermittent Connection 1 1
Inaccurate Flow Rate 1 1
Charred 1 1
Complete Blockage 1 1
Failure to Conduct 1 1
Contamination 1 1
Intermittent Continuity 1 1
Use of Incorrect Control Settings 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Defective Alarm 1 1
Low Audible Alarm 1 1
Difficult or Delayed Activation 1 1
Physical Resistance 1 1
Volume Accuracy Problem 1 1
Device Contamination with Body Fluid 1 1
Intermittent Infusion 1 1
Device Damaged by Another Device 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1
Pre Or Post-Pumping Problem 1 1
Unstable 1 1
Smoking 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1
Device Handling Problem 1 1
Intermittent Communication Failure 1 1
Improper Device Output 1 1
Improper Flow or Infusion 1 1
Inappropriate or Unexpected Reset 1 1
Failure to Shut Off 1 1
Operating System Becomes Nonfunctional 1 1
Naturally Worn 1 1
Material Deformation 1 1
Material Distortion 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 39 39
No Known Impact Or Consequence To Patient 22 22
No Information 12 12
Death 4 4
Air Embolism 2 2
Cardiac Arrest 1 1
Hemolysis 1 1
Loss of consciousness 1 1
Blood Loss 1 1

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