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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

MDR Year MDR Reports MDR Events
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 188 188
Pumping Problem 111 111
Appropriate Term/Code Not Available 33 33
Failure to Auto Stop 18 18
Failure to Power Up 18 18
Mechanical Problem 12 12
Unexpected Shutdown 10 10
Decreased Pump Speed 8 8
Output Problem 7 7
Failure to Pump 6 6
Device Slipped 6 6
Fracture 4 4
Mechanical Jam 4 4
Insufficient Information 3 3
Increased Pump Speed 3 3
Communication or Transmission Problem 3 3
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 2 2
Connection Problem 2 2
Use of Device Problem 2 2
Material Rupture 2 2
Display or Visual Feedback Problem 2 2
Inaccurate Flow Rate 2 2
Loss of Power 2 2
Device Alarm System 2 2
No Audible Alarm 2 2
Contamination 2 2
Power Problem 2 2
Infusion or Flow Problem 2 2
Inappropriate or Unexpected Reset 1 1
Protective Measures Problem 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Intermittent Communication Failure 1 1
Noise, Audible 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Intermittent Continuity 1 1
Display Difficult to Read 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Break 1 1
Complete Blockage 1 1
Failure to Conduct 1 1
Overheating of Device 1 1
Electrical /Electronic Property Problem 1 1
Gas Output Problem 1 1
Failure to Sense 1 1
Smoking 1 1
Unstable 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Contamination with Body Fluid 1 1
Intermittent Infusion 1 1
Difficult or Delayed Activation 1 1
Calibration Problem 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 219 219
No Consequences Or Impact To Patient 125 125
No Patient Involvement 108 108
No Known Impact Or Consequence To Patient 6 6
Air Embolism 2 2
Cardiac Arrest 1 1
Hemolysis 1 1
Low Blood Pressure/ Hypotension 1 1
No Information 1 1
Cerebral Edema 1 1
Insufficient Information 1 1
Brain Injury 1 1
Loss of consciousness 1 1

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