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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, warming. blood and plasma
Regulation Description Blood and plasma warming device.
Product CodeKZL
Regulation Number 864.9205
Device Class 2

MDR Year MDR Reports MDR Events
2020 53 53
2021 71 71
2022 102 102
2023 106 106
2024 57 57
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 190 190
Leak/Splash 83 83
Deformation Due to Compressive Stress 22 22
Scratched Material 18 18
Break 17 17
Connection Problem 15 15
Infusion or Flow Problem 14 14
Fitting Problem 12 12
Obstruction of Flow 11 11
Component Missing 9 9
Disconnection 8 8
Improper Flow or Infusion 8 8
Material Separation 7 7
Crack 7 7
Device Damaged Prior to Use 7 7
Insufficient Flow or Under Infusion 6 6
Detachment of Device or Device Component 6 6
Defective Component 6 6
Overheating of Device 5 5
Fracture 4 4
Separation Problem 4 4
Material Twisted/Bent 3 3
No Pressure 3 3
Pressure Problem 3 3
Mechanical Problem 3 3
Material Split, Cut or Torn 3 3
Excessive Heating 3 3
Loose or Intermittent Connection 3 3
Defective Device 3 3
Free or Unrestricted Flow 3 3
Device Alarm System 3 3
Collapse 2 2
Partial Blockage 2 2
No Audible Alarm 2 2
Insufficient Heating 2 2
Priming Problem 2 2
Audible Prompt/Feedback Problem 2 2
Misassembled 2 2
Positioning Problem 2 2
Material Deformation 2 2
Device Contamination with Body Fluid 1 1
Inaccurate Delivery 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Prime 1 1
Failure to Pump 1 1
Failure to Sense 1 1
Material Too Rigid or Stiff 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 340 340
Insufficient Information 31 31
No Consequences Or Impact To Patient 25 25
No Patient Involvement 23 23
No Information 10 10
Death 6 6
Low Blood Pressure/ Hypotension 3 3
Hypothermia 3 3
Hypovolemic Shock 1 1
Abdominal Distention 1 1
Patient Problem/Medical Problem 1 1

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