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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, pump, infusion
Regulation Description Infusion pump.
Product CodeMRZ
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
AIDERA AB
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANIMAS
  SUBSTANTIALLY EQUIVALENT 1
DATREND SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
SOOIL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 131
Excess flow or overinfusion 7
No Known Device Problem 5
Device alarm system issue 4
Temperature issue 3
Spark 3
Melted 3
Smoking 2
Battery issue 2
No code available 2
Electrical shorting 1
Power source issue 1
Total Device Problems 164

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Dec-03-2009

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