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TPLC
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Device
device, warming. blood and plasma
Regulation Description
Blood and plasma warming device.
Product Code
KZL
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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