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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
Device Slipped 6 6
Failure to Pump 6 6
Fracture 4 4
Mechanical Jam 4 4
Increased Pump Speed 3 3
Insufficient Information 3 3
Communication or Transmission Problem 3 3
Activation, Positioning or Separation Problem 3 3
No Audible Alarm 2 2
Use of Device Problem 2 2
Connection Problem 2 2
Infusion or Flow Problem 2 2
Inaccurate Flow Rate 2 2
Contamination 2 2
Power Problem 2 2
Detachment of Device or Device Component 2 2
Display or Visual Feedback Problem 2 2
Material Rupture 2 2
Device Alarm System 2 2
Loss of Power 2 2
Complete Blockage 1 1
Protective Measures Problem 1 1
Device Damaged by Another Device 1 1
Unintended Movement 1 1
Intermittent Infusion 1 1
Erratic or Intermittent Display 1 1
Mechanics Altered 1 1
Difficult or Delayed Activation 1 1
Failure to Conduct 1 1
Noise, Audible 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Calibration Problem 1 1
Overheating of Device 1 1
Break 1 1
Device Contamination with Body Fluid 1 1
Display Difficult to Read 1 1
Unstable 1 1
Failure to Sense 1 1
Inappropriate or Unexpected Reset 1 1
Electrical /Electronic Property Problem 1 1
Intermittent Continuity 1 1
Intermittent Communication Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Smoking 1 1
No Apparent Adverse Event 1 1
No Display/Image 1 1
Gas Output Problem 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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