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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
set, transfer (blood/plasma)
Product Code
KSB
Regulation Number
864.9875
Device Class
2
Premarket Reviews
Manufacturer
Decision
CHARTER MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
GENESISBPS, LLC
SUBSTANTIALLY EQUIVALENT
2
KAWASUMI LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
TERUMO BCT, INC
SUBSTANTIALLY EQUIVALENT
2
TERUMO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
WUHAN BMS MEDICALTECH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
1
1
2016
1
1
2017
26
26
2018
9
9
2019
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
25
25
Use of Device Problem
10
10
Break
9
9
Contamination
8
8
Contamination of Device Ingredient or Reagent
8
8
Leak/Splash
7
7
Microbial Contamination of Device
7
7
Appropriate Term/Code Not Available
6
6
Dent in Material
5
5
Separation Failure
5
5
Ejection Problem
4
4
Device Operates Differently Than Expected
4
4
Material Integrity Problem
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Activation, Positioning or Separation Problem
2
2
Positioning Failure
2
2
Failure to Eject
1
1
Expiration Date Error
1
1
Contamination /Decontamination Problem
1
1
Unintended Ejection
1
1
Material Discolored
1
1
Fluid/Blood Leak
1
1
Inadequate User Interface
1
1
Detachment Of Device Component
1
1
Thermal Decomposition of Device
1
1
Structural Problem
1
1
Mechanics Altered
1
1
Improper or Incorrect Procedure or Method
1
1
Device Displays Incorrect Message
1
1
No Apparent Adverse Event
1
1
Product Quality Problem
1
1
Free or Unrestricted Flow
1
1
Device Contamination With Biological Material
1
1
Failure to Advance
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
40
40
No Patient Involvement
8
8
No Code Available
3
3
No Consequences Or Impact To Patient
2
2
No Information
1
1
Hepatitis
1
1
Fever
1
1
Chills
1
1
Reaction
1
1
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