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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
Regulation Description Blood and plasma warming device.
Product CodeBSB
Regulation Number 864.9205
Device Class 2

MDR Year MDR Reports MDR Events
2021 340 343
2022 447 447
2023 290 291
2024 282 282
2025 198 198
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 391 391
Device Alarm System 149 149
Temperature Problem 98 98
Pressure Problem 85 85
Insufficient Heating 70 70
Insufficient Flow or Under Infusion 66 66
Overheating of Device 59 59
Leak/Splash 47 47
Defective Component 36 36
Break 35 35
Failure to Pump 35 35
Defective Alarm 35 35
Device Markings/Labelling Problem 35 35
Excessive Heating 33 33
Insufficient Information 33 33
Failure to Power Up 32 32
False Alarm 24 24
Component Missing 24 24
Infusion or Flow Problem 23 23
Noise, Audible 23 23
Power Problem 22 22
Fracture 21 21
Inflation Problem 20 20
Mechanical Problem 20 20
Device Sensing Problem 20 20
Failure to Calibrate 20 20
No Flow 16 16
Crack 16 16
Decrease in Pressure 15 15
Electrical /Electronic Property Problem 15 15
Failure to Infuse 15 15
Calibration Problem 14 14
Device Emits Odor 14 14
Connection Problem 13 13
Failure to Sense 13 13
No Display/Image 12 12
Air/Gas in Device 12 12
Incorrect, Inadequate or Imprecise Result or Readings 12 12
No Audible Alarm 11 12
Defective Device 11 12
Circuit Failure 11 11
Display or Visual Feedback Problem 11 11
Pumping Problem 10 10
Improper Flow or Infusion 10 10
Inaccurate Delivery 9 9
Output below Specifications 9 9
Failure to Deliver 9 9
No Pressure 9 9
Key or Button Unresponsive/not Working 8 8
Obstruction of Flow 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1329 1332
Insufficient Information 296 299
No Consequences Or Impact To Patient 26 26
No Patient Involvement 15 15
No Information 3 3
Air Embolism 2 2
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 2
Burning Sensation 1 1
Unspecified Heart Problem 1 1
Hemorrhage/Bleeding 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Company I Sep-18-2025
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