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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 256 256

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 417 417
Device Alarm System 203 203
Temperature Problem 120 120
Pressure Problem 99 99
Insufficient Flow or Under Infusion 70 70
Leak/Splash 66 66
Insufficient Heating 65 65
Overheating of Device 51 51
Break 39 39
Defective Component 38 38
False Alarm 35 35
Defective Alarm 35 35
Device Markings/Labelling Problem 35 35
Failure to Power Up 34 34
Insufficient Information 33 33
Noise, Audible 30 30
Failure to Pump 28 28
Power Problem 27 27
Excessive Heating 27 27
Mechanical Problem 26 26
Component Missing 24 24
Infusion or Flow Problem 24 24
Device Sensing Problem 23 23
Decrease in Pressure 22 22
Failure to Calibrate 22 22
Crack 21 21
Fracture 19 19
Inflation Problem 18 18
Electrical /Electronic Property Problem 16 16
Calibration Problem 16 16
No Flow 16 16
Connection Problem 16 16
No Audible Alarm 15 15
Defective Device 14 14
Device Emits Odor 13 13
No Display/Image 12 12
Display or Visual Feedback Problem 11 11
Improper Flow or Infusion 10 10
No Pressure 10 10
Pumping Problem 10 10
Air/Gas in Device 10 10
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Output Problem 9 9
Output below Specifications 9 9
Unexpected Shutdown 8 8
Failure to Deliver 8 8
Failure to Sense 8 8
Inaccurate Delivery 8 8
Detachment of Device or Device Component 7 7
Key or Button Unresponsive/not Working 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1101 1101
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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