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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hemodialyzer, re-use, high flux
Regulation Description High permeability hemodialysis system.
Product CodeMSF
Regulation Number 876.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 116
Dialyzer, failure of 39
Rupture, cause unknown 8
Unknown (for use when the device problem is not known) 4
Device contamination with blood or blood product 1
Difficult or delayed activation 1
No Known Device Problem 1
Pressure issue 1
Leak 1
Occlusion within device 1
Device Difficult to Setup or Prepare 1
Reaction 1
Deionizer, failure of 1
Total Device Problems 176

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