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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, blood-gas, on-line, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass on-line blood gas monitor.
Product CodeDRY
Regulation Number 870.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 5
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SORIN
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM
  SUBSTANTIALLY EQUIVALENT 5
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 519
Break 397
Incorrect or inadequate result 394
Leak 357
Device operates differently than expected 254
Battery issue 161
Crack 140
Fracture 135
Naturally worn 122
Connection issue 105
Failure of device to self-test 101
Incorrect or inadequate test results 88
Failure to calibrate 81
Scratched material 70
Failure to power-up 62
Calibration error 61
Corrosion 51
Output issue 50
Fluid leak 44
No display or display failure 39
Device inoperable 38
Unable to obtain readings 32
Improper device output 32
Component missing 32
Material frayed 28
Material separation 26
Device damaged prior to use 22
Incorrect display 21
Calibration issue 20
Loose or intermittent connection 15
Difficult to position 13
Fitting problem 13
High Readings 13
Device Issue 12
Peeled 12
Difficult to deploy 12
Intermittent continuity 11
Device markings issue 11
Device sensing issue 10
Device stops intermittently 10
Burn of device or device component 10
Material integrity issue 9
Data Issue 9
Power source issue 8
Foreign material present in device 8
Failure to charge 8
Failure to sense 8
Volume accuracy issue 8
Computer software issue 7
Low readings 7
Material Protrusion 7
Infusion or flow issue 6
Issue with displayed error message 6
Cut in material 6
Out-of-box failure 6
Gas leak 6
Communication or transmission issue 6
Ambient noise issue 6
False alarm 6
Material discolored 6
Smoking 6
Nonstandard device or device component 6
No device output 5
Erratic display 5
Material fragmentation 5
Circuit Failure 5
Impedance issue 5
Improper flow or infusion 5
No flow 4
Charging issue 4
High test results 4
Device alarm system issue 4
Bent 4
Electrical issue 4
Device emits odor 4
Poor quality image 4
Mechanical issue 4
Device Difficult to Setup or Prepare 4
Pitted 3
Power Conditioning Issue 3
False device output 3
Low test results 3
Deployment issue 3
Electronic property issue 3
Environmental Particulates 3
Pressure issue 3
No code available 3
Material Distortion 2
Temperature issue 2
No Known Device Problem 2
Overcorrection 2
Mechanical jam 2
Dent in material 2
Split 2
Defective component 2
Improper gas output 2
Air leak 2
Detachment of device component 2
Loss of power 2
Overheating of device or device component 2
Total Device Problems 3892

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 1 0 0 4 3 2 1 1 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic International Trade Inc II Jul-30-2008
2 Terumo Cardiovascular Systems Corporation II Mar-25-2016
3 Terumo Cardiovascular Systems Corporation II Sep-09-2015
4 Terumo Cardiovascular Systems Corporation II May-19-2014
5 Terumo Cardiovascular Systems Corporation II Jul-13-2013
6 Terumo Cardiovascular Systems Corporation II Feb-12-2013
7 Terumo Cardiovascular Systems Corporation II Apr-06-2012
8 Terumo Cardiovascular Systems Corporation II Jan-11-2012
9 Terumo Cardiovascular Systems Corporation II Jan-11-2012
10 Terumo Cardiovascular Systems Corporation II Oct-31-2011
11 Terumo Cardiovascular Systems Corporation II Jun-28-2011
12 Terumo Cardiovascular Systems Corporation II Jun-22-2011
13 Terumo Cardiovascular Systems Corporation II May-12-2011

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