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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device set, blood transfusion
Regulation Description Intravascular administration set.
Product CodeBRZ
Regulation Number 880.5440
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CHARTER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JMS
  SUBSTANTIALLY EQUIVALENT 1
PENTAFERTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 56
Disconnection 43
Failure to infuse 7
Device operates differently than expected 6
Foreign material present in device 6
Failure to prime 6
Filling problem 5
Crack 5
Hole in material 5
Kinked 3
Device displays error message 3
No flow 3
Material deformation 2
Particulates 2
Leak 2
Cut in material 2
Break 2
Clumping in device or device ingredient 1
Detachment of device component 1
Blockage within device or device component 1
Filter 1
Difficult to flush 1
Reflux within device 1
Material separation 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Fitting problem 1
Other (for use when an appropriate device code cannot be identified) 1
Material perforation 1
Failure to disconnect 1
Obstruction within device 1
Occlusion within device 1
Malposition of device 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Free or unrestricted flow 1
Improper flow or infusion 1
Infusion or flow issue 1
Material integrity issue 1
No Known Device Problem 1
Total Device Problems 181

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