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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
Product CodeDWB
Regulation Number 870.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 63 63
2015 122 122
2016 318 318
2017 361 361
2018 258 258
2019 155 155
2020 79 79
2021 58 58
2022 87 87
2023 64 64
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 330 330
Device Displays Incorrect Message 298 298
No Display/Image 284 284
Pumping Problem 129 129
Device Operates Differently Than Expected 73 73
Appropriate Term/Code Not Available 60 60
Device Operational Issue 59 59
Failure to Pump 53 53
Display or Visual Feedback Problem 48 48
Break 31 31
Failure to Power Up 30 30
Failure to Auto Stop 25 25
Mechanical Jam 21 21
Device Stops Intermittently 20 20
Mechanical Problem 19 19
Fracture 17 17
Other (for use when an appropriate device code cannot be identified) 17 17
Detachment Of Device Component 15 15
Output Problem 14 14
Loss of Power 13 13
Decreased Pump Speed 12 12
Unexpected Shutdown 11 11
Communication or Transmission Problem 9 9
Erratic or Intermittent Display 9 9
Image Display Error/Artifact 8 8
False Alarm 8 8
Device Inoperable 8 8
Positioning Problem 8 8
Connection Problem 7 7
Device Issue 7 7
Device Slipped 6 6
Device Alarm System 6 6
Fluid/Blood Leak 5 5
Increased Pump Speed 5 5
Power Problem 5 5
Detachment of Device or Device Component 5 5
Device Markings/Labelling Problem 5 5
Noise, Audible 5 5
Infusion or Flow Problem 4 4
Protective Measures Problem 4 4
Calibration Problem 4 4
Component Missing 4 4
Crack 4 4
No Audible Alarm 4 4
Alarm Not Visible 3 3
Incorrect Measurement 3 3
Overheating of Device 3 3
Inaccurate Flow Rate 3 3
Activation, Positioning or Separation Problem 3 3
Suction Problem 3 3
Insufficient Flow or Under Infusion 3 3
Material Rupture 3 3
No Flow 3 3
Insufficient Information 3 3
Physical Property Issue 2 2
Material Deformation 2 2
Human Factors Issue 2 2
Difficult to Open or Close 2 2
Sticking 2 2
Decrease in Pressure 2 2
Device Contamination with Body Fluid 2 2
Use of Device Problem 2 2
Display Difficult to Read 2 2
Electrical /Electronic Property Problem 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Thermal Decomposition of Device 2 2
Contamination 2 2
Intermittent Continuity 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Defective Alarm 1 1
Low Audible Alarm 1 1
Failure to Conduct 1 1
Charred 1 1
Complete Blockage 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Difficult To Position 1 1
Moisture Damage 1 1
Occlusion Within Device 1 1
Gas Output Problem 1 1
Volume Accuracy Problem 1 1
Unstable 1 1
Intermittent Infusion 1 1
Difficult or Delayed Activation 1 1
Physical Resistance 1 1
Pre Or Post-Pumping Problem 1 1
Product Quality Problem 1 1
Device Remains Activated 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Smoking 1 1
Failure to Sense 1 1
Fail-Safe Problem 1 1
Device Damaged by Another Device 1 1
Device Sensing Problem 1 1
Difficult to Advance 1 1
Improper Device Output 1 1
Improper Flow or Infusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 657 657
No Patient Involvement 618 618
No Clinical Signs, Symptoms or Conditions 219 219
No Known Impact Or Consequence To Patient 46 46
No Information 17 17
Not Applicable 10 10
No Patient involvement 9 9
Death 5 5
Air Embolism 3 3
Loss of consciousness 2 2
Low Blood Pressure/ Hypotension 2 2
Cerebral Edema 1 1
Insufficient Information 1 1
Blood Loss 1 1
Brain Injury 1 1
Injury 1 1
Cardiac Arrest 1 1
Hemolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Nov-29-2011
2 Terumo Cardiovascular Systems Corporation II Sep-15-2011
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