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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, transfer (blood/plasma)
Product CodeKSB
Regulation Number 864.9875
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Material Discolored 1 1
Unintended Ejection 1 1
Fluid/Blood Leak 1 1
Thermal Decomposition of Device 1 1
Detachment Of Device Component 1 1
Product Quality Problem 1 1
Device Displays Incorrect Message 1 1
Contamination /Decontamination Problem 1 1
Expiration Date Error 1 1
Structural Problem 1 1
Failure to Advance 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination With Biological Material 1 1
Free or Unrestricted Flow 1 1
Inadequate User Interface 1 1
No Apparent Adverse Event 1 1
Mechanics Altered 1 1
Failure to Eject 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
Reaction 1 1
Fever 1 1
Hepatitis 1 1
Chills 1 1
No Information 1 1

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