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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Product CodeFIP
Regulation Number 876.5665
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERIWATER
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
MAR COR
  SUBSTANTIALLY EQUIVALENT 1
  1.  K133149  BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYS ...
VIVONIC GMBH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Thermal Decomposition of Device 4
Misassembly during Maintenance / Repair 2
Flushing problem 2
Filtration Problem 2
Fitting Problem 2
Material Integrity Problem 2
Device Reprocessing Problem 2
Material Disintegration 2
Contamination / decontamination Problem 2
Adverse Event Without Identified Device or Use Problem 2
Loss of or Failure to Bond 2
Melted 1
Electrical /Electronic Property Problem 1
Sparking 1
Water Purification System 1
Misconnection 1
Inadequate Filtration Process 1
Component Incompatible 1
Misassembly by Users 1
Device Handling Problem 1
Overheating of Device 1
Solenoid 1
Total Device Problems 35

Recalls
Manufacturer Recall Class Date Posted
1 Mar Cor Purification II May-06-2014
2 Mar Cor Purification II Mar-14-2014
3 Mar Cor Purification II Mar-13-2014

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