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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

MDR Year MDR Reports MDR Events
2019 155 155
2020 79 79
2021 58 58
2022 87 87
2023 49 49
2024 39 39
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 191 191
Pumping Problem 109 109
Appropriate Term/Code Not Available 33 33
Failure to Power Up 19 19
Failure to Auto Stop 18 18
Unexpected Shutdown 10 10
Mechanical Problem 10 10
Decreased Pump Speed 8 8
Output Problem 7 7
Device Slipped 6 6
Failure to Pump 6 6
Mechanical Jam 4 4
Fracture 4 4
Activation, Positioning or Separation Problem 3 3
Communication or Transmission Problem 3 3
Insufficient Information 3 3
Increased Pump Speed 3 3
Loss of Power 2 2
Device Alarm System 2 2
Display or Visual Feedback Problem 2 2
Connection Problem 2 2
No Audible Alarm 2 2
Contamination 2 2
Use of Device Problem 2 2
Power Problem 2 2
Material Rupture 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 1 1
Fluid/Blood Leak 1 1
Intermittent Communication Failure 1 1
Electrical /Electronic Property Problem 1 1
Inappropriate or Unexpected Reset 1 1
Overheating of Device 1 1
Intermittent Continuity 1 1
Protective Measures Problem 1 1
Erratic or Intermittent Display 1 1
Failure to Conduct 1 1
No Apparent Adverse Event 1 1
Calibration Problem 1 1
Intermittent Infusion 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Mechanics Altered 1 1
Infusion or Flow Problem 1 1
Device Damaged by Another Device 1 1
Inaccurate Flow Rate 1 1
Difficult or Delayed Activation 1 1
Microbial Contamination of Device 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Smoking 1 1
Failure to Sense 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 221 221
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
Hemolysis 1 1
Brain Injury 1 1
Hematuria 1 1
No Information 1 1
Cardiac Arrest 1 1
Insufficient Information 1 1
Bacterial Infection 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1
Cerebral Edema 1 1

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