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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, blood, non-electromagnetic radiation
Product CodeBSB
Regulation Number 864.9205
Device Class 2

MDR Year MDR Reports MDR Events
2019 147 147
2020 216 216
2021 341 341
2022 447 447
2023 292 292
2024 205 205

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 402 402
Device Alarm System 198 198
Temperature Problem 118 118
Pressure Problem 97 97
Insufficient Flow or Under Infusion 69 69
Leak/Splash 65 65
Insufficient Heating 63 63
Overheating of Device 49 49
Break 39 39
Defective Component 36 36
False Alarm 35 35
Device Markings/Labelling Problem 35 35
Failure to Power Up 34 34
Defective Alarm 33 33
Insufficient Information 33 33
Noise, Audible 30 30
Failure to Pump 27 27
Power Problem 27 27
Mechanical Problem 26 26
Infusion or Flow Problem 24 24
Component Missing 24 24
Decrease in Pressure 22 22
Device Sensing Problem 22 22
Failure to Calibrate 22 22
Crack 20 20
Excessive Heating 20 20
Inflation Problem 18 18
Fracture 17 17
Calibration Problem 16 16
Electrical /Electronic Property Problem 16 16
Connection Problem 16 16
No Flow 15 15
No Audible Alarm 14 14
Defective Device 14 14
No Display/Image 12 12
Device Emits Odor 11 11
Display or Visual Feedback Problem 11 11
Improper Flow or Infusion 10 10
No Pressure 10 10
Air/Gas in Device 10 10
Pumping Problem 10 10
Output below Specifications 9 9
Output Problem 9 9
Failure to Sense 8 8
Inaccurate Delivery 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Failure to Deliver 8 8
Inaccurate Flow Rate 7 7
Unexpected Shutdown 7 7
Detachment of Device or Device Component 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1050 1050
Insufficient Information 296 296
No Information 123 123
No Patient Involvement 105 105
No Consequences Or Impact To Patient 72 72
Not Applicable 61 61
No Known Impact Or Consequence To Patient 52 52
Death 5 5
Air Embolism 2 2
Burn(s) 2 2
Non specific EKG/ECG Changes 1 1
Hypovolemic Shock 1 1
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Code Available 1 1
Blood Loss 1 1
Cardiac Arrest 1 1
Septic Shock 1 1
Unspecified Heart Problem 1 1
Hemorrhage/Bleeding 1 1

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