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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
2018 258 258
2019 155 155
2020 79 79
2021 59 59
2022 87 87
2023 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 181 181
Pumping Problem 102 102
Appropriate Term/Code Not Available 60 60
Device Displays Incorrect Message 57 57
No Display/Image 53 53
Display or Visual Feedback Problem 35 35
Failure to Power Up 19 19
Failure to Auto Stop 18 18
Mechanical Problem 15 15
Output Problem 14 14
Unexpected Shutdown 11 11
Decreased Pump Speed 8 8
Device Operates Differently Than Expected 7 7
Mechanical Jam 7 7
Loss of Power 6 6
Device Slipped 6 6
Fracture 6 6
Break 5 5
Communication or Transmission Problem 5 5
Connection Problem 5 5
Erratic or Intermittent Display 4 4
Increased Pump Speed 3 3
Failure to Pump 3 3
Device Alarm System 3 3
Image Display Error/Artifact 3 3
Activation, Positioning or Separation Problem 3 3
Power Problem 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 2 2
Device Markings/Labelling Problem 2 2
Use of Device Problem 2 2
Component Missing 2 2
Leak/Splash 2 2
Electrical /Electronic Property Problem 2 2
False Alarm 2 2
No Audible Alarm 2 2
Contamination 2 2
Display Difficult to Read 2 2
Material Rupture 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Smoking 1 1
Device Inoperable 1 1
Unstable 1 1
Overheating of Device 1 1
Intermittent Continuity 1 1
Complete Blockage 1 1
Failure to Conduct 1 1
Alarm Not Visible 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1
Device Contamination with Body Fluid 1 1
Intermittent Infusion 1 1
Device Issue 1 1
Difficult or Delayed Activation 1 1
Insufficient Flow or Under Infusion 1 1
Calibration Problem 1 1
Improper Flow or Infusion 1 1
Inappropriate or Unexpected Reset 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Intermittent Communication Failure 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Unintended Movement 1 1
Operating System Becomes Nonfunctional 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 245 245
No Patient Involvement 241 241
No Clinical Signs, Symptoms or Conditions 151 151
No Known Impact Or Consequence To Patient 11 11
No Information 1 1
Cerebral Edema 1 1
Brain Injury 1 1
Loss of consciousness 1 1
Blood Loss 1 1
Air Embolism 1 1
Cardiac Arrest 1 1
Hemolysis 1 1
Low Blood Pressure/ Hypotension 1 1

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