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TPLC
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show TPLC since
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Device
set, blood transfusion
Product Code
BRZ
Regulation Number
880.5440
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTERIOCYTE MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
BAXTER HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
108
108
2015
171
171
2016
78
78
2017
82
82
2018
66
66
2019
85
99
2020
90
90
2021
60
60
2022
55
55
2023
67
67
2024
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
382
392
Disconnection
151
156
No Flow
48
48
Break
44
44
Crack
41
41
Leak/Splash
36
36
Filling Problem
35
35
Device Operates Differently Than Expected
30
30
Device Contamination with Chemical or Other Material
26
26
Failure to Prime
25
25
Material Puncture/Hole
22
22
Detachment of Device or Device Component
22
22
Hole In Material
19
19
Detachment Of Device Component
18
18
Material Deformation
16
16
Backflow
16
16
Connection Problem
13
13
Cut In Material
12
12
Material Split, Cut or Torn
10
10
Device Displays Incorrect Message
10
10
Failure to Disconnect
10
10
Improper Flow or Infusion
10
11
Air Leak
10
10
Component Missing
9
9
Material Separation
9
9
Fitting Problem
8
8
Failure to Infuse
8
8
Reflux within Device
7
7
Infusion or Flow Problem
7
7
Defective Component
6
6
Improper or Incorrect Procedure or Method
5
5
Complete Blockage
5
5
Kinked
5
5
Melted
5
5
Obstruction of Flow
5
5
Material Twisted/Bent
4
4
Material Perforation
4
4
Air/Gas in Device
4
4
Material Rupture
4
4
Fracture
4
4
Protective Measures Problem
4
4
Misconnection
3
3
Free or Unrestricted Flow
3
3
Scratched Material
3
3
Contamination /Decontamination Problem
3
3
Material Integrity Problem
3
3
Defective Device
3
3
Component Falling
2
2
Mechanical Problem
2
2
Occlusion Within Device
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
263
268
No Patient Involvement
260
262
No Clinical Signs, Symptoms or Conditions
221
221
No Known Impact Or Consequence To Patient
145
152
Insufficient Information
10
10
Low Blood Pressure/ Hypotension
4
4
No Information
3
3
Blood Loss
3
3
Exposure to Body Fluids
3
3
Cardiac Arrest
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Death
1
1
No Code Available
1
1
Respiratory Arrest
1
1
Inflammation
1
1
Overdose
1
1
Discomfort
1
1
Dyspnea
1
1
Bradycardia
1
1
Reaction
1
1
Shaking/Tremors
1
1
Hemorrhage/Bleeding
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Genesis BPS, LLC.
II
Sep-18-2014
2
Hospira Inc.
I
Aug-05-2013
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