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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sensor, blood-gas, in-line, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass in-line blood gas sensor.
Product CodeDTY
Regulation Number 870.4410
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 59
Device operates differently than expected 39
Battery issue 27
Failure to power-up 27
Break 19
Fracture 19
No display or display failure 15
Device inoperable 14
Communication or transmission issue 11
Calibration issue 9
Failure to calibrate 7
Leak 6
Component missing 6
Crack 4
Charging issue 4
Fluid leak 4
Unable to obtain readings 3
Incorrect or inadequate result 3
Incorrect or inadequate test results 3
Failure to charge 3
Detachment of device component 3
Data Issue 3
No Information 2
Connection issue 2
Material Protrusion 2
Loose or intermittent connection 2
Ambient noise issue 2
Aborted charge 2
Device damaged prior to use 1
Failure to sense 1
Material separation 1
Device stops intermittently 1
Low readings 1
Failure to advance 1
Low battery 1
Image display error 1
Image orientation incorrect 1
Material disintegration 1
Erratic display 1
Incorrect display 1
False device output 1
Component falling 1
Corrosion 1
Circuit Failure 1
Device clogged 1
Calibration error 1
Failure to run on AC/DC 1
Device alarm system issue 1
Bent 1
Output issue 1
Failure of device to self-test 1
Improper device output 1
Material integrity issue 1
Total Device Problems 325

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 0 0 1 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 Corporation II Apr-11-2011

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