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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 50 50
2024 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 191 191
Pumping Problem 110 110
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
Display or Visual Feedback Problem 2 2
Connection Problem 2 2
Power Problem 2 2
Detachment of Device or Device Component 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Contamination 2 2
No Audible Alarm 2 2
Device Alarm System 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Microbial Contamination of Device 1 1
Smoking 1 1
Difficult or Delayed Activation 1 1
Inaccurate Flow Rate 1 1
Device Damaged by Another Device 1 1
Infusion or Flow Problem 1 1
Mechanics Altered 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Sense 1 1
Intermittent Infusion 1 1
Calibration Problem 1 1
Unintended Movement 1 1
Complete Blockage 1 1
No Apparent Adverse Event 1 1
Failure to Conduct 1 1
Erratic or Intermittent Display 1 1
Display Difficult to Read 1 1
Protective Measures Problem 1 1
Device Contamination with Body Fluid 1 1
Intermittent Continuity 1 1
No Display/Image 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 222 222
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
Low Blood Pressure/ Hypotension 2 2
Hemolysis 1 1
Brain Injury 1 1
No Information 1 1
Hematuria 1 1
Cardiac Arrest 1 1
Insufficient Information 1 1
Loss of consciousness 1 1
Bacterial Infection 1 1
Cerebral Edema 1 1

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