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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
Product CodeKZL
Regulation Number 864.9205
Device Class 2


Premarket Reviews
ManufacturerDecision
FREMON SCIENTIFIC INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 53 53
2021 71 71
2022 102 102
2023 106 106
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 154 154
Leak/Splash 78 78
Deformation Due to Compressive Stress 22 22
Scratched Material 18 18
Break 16 16
Connection Problem 15 15
Infusion or Flow Problem 14 14
Component Missing 9 9
Obstruction of Flow 9 9
Improper Flow or Infusion 8 8
Device Damaged Prior to Use 7 7
Crack 6 6
Defective Component 5 5
Material Separation 5 5
Detachment of Device or Device Component 5 5
Fitting Problem 3 3
Fracture 3 3
Disconnection 3 3
No Pressure 3 3
Pressure Problem 3 3
Material Split, Cut or Torn 3 3
Audible Prompt/Feedback Problem 2 2
Priming Problem 2 2
Separation Problem 2 2
Positioning Problem 2 2
Material Deformation 2 2
Device Alarm System 2 2
Partial Blockage 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Misassembled 2 2
Free or Unrestricted Flow 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Insufficient Flow or Under Infusion 1 1
Failure to Align 1 1
Defective Device 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Prime 1 1
Product Quality Problem 1 1
Failure to Sense 1 1
Insufficient Heating 1 1
Deflation Problem 1 1
Loss of or Failure to Bond 1 1
Contamination 1 1
Unintended Ejection 1 1
Restricted Flow rate 1 1
Inaccurate Flow Rate 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Output Problem 1 1
Incomplete or Inadequate Connection 1 1
Pumping Problem 1 1
Temperature Problem 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 257 257
No Consequences Or Impact To Patient 25 25
Insufficient Information 25 25
No Patient Involvement 23 23
No Information 10 10
Death 7 7
Low Blood Pressure/ Hypotension 3 3
Hypothermia 3 3
Abdominal Distention 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

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