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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device oxygenator, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass oxygenator.
Product CodeDTZ
Regulation Number 870.4350
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 10
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 9
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 1
COBE INC.
  SUBSTANTIALLY EQUIVALENT 8
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DIDECO
  SUBSTANTIALLY EQUIVALENT 10
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
JOSTRA
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 13
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 19
MINNTECH
  SUBSTANTIALLY EQUIVALENT 4
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NOVALUNG GMBH
  SUBSTANTIALLY EQUIVALENT 1
POLYSTAN
  SUBSTANTIALLY EQUIVALENT 4
SCIMED
  SUBSTANTIALLY EQUIVALENT 6
SECHRIST INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 10
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 22

Device Problems
Leak 685
Fluid leak 473
Device damaged prior to use 137
Device operates differently than expected 117
Increase in pressure 105
Other (for use when an appropriate device code cannot be identified) 99
Use of Device Issue 89
Device Issue 79
Malfunction 65
Pressure issue 63
Tears, rips, holes in device, device material 52
Foreign material present in device 50
Membrane leak(s) 50
Poor gas exchange 47
Crack 45
Device clogged 43
Filtration issue 42
Connection issue 38
Fracture 37
Replace 37
Air leak 35
Failure to Adhere or Bond 35
Break 34
Improper flow or infusion 33
Coagulation in device or device ingredient 31
Disconnection 28
Occlusion within device 27
Out-of-box failure 26
Performance 24
Restricted flowrate 23
Infusion or flow issue 23
Medical Gas Supply problem 19
Gradient increase 16
No Known Device Problem 15
Insufficient flow or underinfusion 14
No flow 13
Detachment of device component 13
Loose or intermittent connection 12
Output issue 11
Defective component 11
Decrease in pressure 11
Device displays error message 11
Blockage within device or device component 10
Component missing 9
Unknown (for use when the device problem is not known) 9
Temperature issue 9
Incorrect device or component shipped 9
Packaging issue 8
Tear, rip or hole in device packaging 8
Obstruction within device 8
Improper or incorrect procedure or method 7
Tube(s), splitting of 7
Pumping stopped 7
Kinked 6
Material deformation 6
No Information 5
No code available 4
Manufacturing or shipping issue associated with device 4
Shipping damage or problem 4
Improper gas output 4
Bubble(s) 4
Device alarm system issue 3
Not audible alarm 3
Decoupling 3
Misassembled 3
Heat, failure to 3
Insufficient heating 3
Hole in material 3
Device Difficult to Setup or Prepare 3
Failure to sense 3
Port leak(s) 3
Failure to prime 3
Noise 3
Fitting problem 3
Inaccurate delivery 3
Dent in material 3
Material integrity issue 3
Pumping issue 3
Device markings issue 3
Device misassembled during manufacturing or shipping 3
Dislodged or dislocated 3
Excessive cooling 2
Detachment of device or device component 2
Item contaminated during manufacturing or shipping 2
Improper device output 2
Ventilation issue in device environment 2
Positioning Issue 2
Power source issue 2
Locking mechanism failure 2
Sharp/jagged/rough/etched/scratched 2
Implant Mobility NOS (Not otherwise specified) 2
Incomplete or missing packaging 2
Material perforation 2
Inadequate filtration process 2
Difficult to position 2
Unsealed device packaging 2
Reservoir 2
Material rupture 2
Product quality issue 2
Gas delivery system failure 2
Total Device Problems 3044

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 1 0 0 0 0 0 0 0 0 0 0
Class II 1 3 1 0 0 5 2 2 1 2 0
Class III 0 1 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. I May-24-2007
2 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
3 Maquet Cardiovascular Us Sales, Llc II May-28-2015
4 Maquet Cardiovascular Us Sales, Llc II Dec-24-2014
5 Maquet Cardiovascular Us Sales, Llc II Sep-20-2013
6 Maquet Cardiovascular Us Sales, Llc II Oct-26-2012
7 Maquet Cardiovascular Us Sales, Llc II Jan-11-2012
8 Medtronic Inc II Dec-20-2016
9 Medtronic Inc II Feb-09-2009
10 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
11 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
12 Medtronic Perfusion Systems II Dec-16-2014
13 Medtronic Perfusion Systems II Jul-24-2008
14 Medtronic Perfusion Systems III Jan-26-2008
15 Medtronic Perfusion Systems II Jul-26-2007
16 Navilyst Medical II Nov-09-2008
17 Sorin Group USA, Inc. II Jan-14-2012
18 Sorin Group USA, Inc. II Sep-30-2008
19 Terumo Cardiovascular Corporation III Jan-24-2012
20 Terumo Cardiovascular Systems Corp II May-11-2012

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