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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor and/or control, level sensing, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass level sensing monitor and/or control.
Product CodeDTW
Regulation Number 870.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 17
Mechanical issue 5
Break 4
Sensor problems 4
Device displays error message 2
No display or display failure 2
Device alarm system issue 2
False alarm 1
Failure to power-up 1
Pumping stopped 1
Unable to obtain readings 1
Failure to sense 1
Connection issue 1
Device operates differently than expected 1
Total Device Problems 43

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 1 0 0 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 Terumo Cardiovascular Systems Corp II Mar-27-2007

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