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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 17
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 661
Fluid leak 464
Device damaged prior to use 130
Device operates differently than expected 115
Other (for use when an appropriate device code cannot be identified) 99
Increase in pressure 88
Use of Device Issue 78
Device Issue 75
Malfunction 65
Tears, rips, holes in device, device material 52
Membrane leak(s) 50
Foreign material present in device 48
Pressure issue 48
Poor gas exchange 47
Device clogged 43
Crack 41
Filtration issue 40
Replace 37
Failure to Adhere or Bond 34
Fracture 28
Air leak 27
Improper flow or infusion 27
Coagulation in device or device ingredient 25
Occlusion within device 25
Performance 24
Disconnection 24
Connection issue 24
Restricted flowrate 23
Out-of-box failure 22
Infusion or flow issue 20
Break 18
Gradient increase 16
No Known Device Problem 14
No flow 12
Insufficient flow or underinfusion 12
Loose or intermittent connection 12
Decrease in pressure 11
Output issue 11
Medical Gas Supply problem 11
Device displays error message 10
Detachment of device component 10
Blockage within device or device component 9
Unknown (for use when the device problem is not known) 9
Pumping stopped 7
Obstruction within device 7
Incorrect device or component shipped 7
Tube(s), splitting of 7
Defective component 6
Component missing 5
Material deformation 5
Manufacturing or shipping issue associated with device 4
No Information 4
No code available 4
Improper or incorrect procedure or method 4
Tear, rip or hole in device packaging 4
Shipping damage or problem 4
Improper gas output 4
Kinked 4
Bubble(s) 4
Not audible alarm 3
Heat, failure to 3
Hole in material 3
Failure to sense 3
Device Difficult to Setup or Prepare 3
Port leak(s) 3
Dent in material 3
Device markings issue 3
Device misassembled during manufacturing or shipping 3
Noise 3
Fitting problem 3
Inaccurate delivery 3
Packaging issue 3
Material integrity issue 3
Dislodged or dislocated 3
Improper device output 2
Positioning Issue 2
Power source issue 2
Device handling issue 2
Pumping issue 2
Ventilation issue in device environment 2
Incomplete or missing packaging 2
Inadequate filtration process 2
Material perforation 2
Detachment of device or device component 2
Locking mechanism failure 2
Sharp/jagged/rough/etched/scratched 2
Implant Mobility NOS (Not otherwise specified) 2
Difficult to position 2
Reservoir 2
Material rupture 2
Unsealed device packaging 2
Misassembled 2
Insufficient heating 2
Gas delivery system failure 2
Foreign material 2
Decoupling 2
Contamination during use 2
Cool, failure to 2
Loss of or failure to bond 2
Bent 1
Total Device Problems 2815

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 1 0 0 0 0 0 0 0 0 0
Class II 1 3 1 0 0 5 2 2 1 1
Class III 0 1 0 0 0 1 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 Feb-09-2009
9 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
10 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
11 Medtronic Perfusion Systems II Dec-16-2014
12 Medtronic Perfusion Systems II Jul-24-2008
13 Medtronic Perfusion Systems III Jan-26-2008
14 Medtronic Perfusion Systems II Jul-26-2007
15 Navilyst Medical II Nov-09-2008
16 Sorin Group USA, Inc. II Jan-14-2012
17 Sorin Group USA, Inc. II Sep-30-2008
18 Terumo Cardiovascular Corporation III Jan-24-2012
19 Terumo Cardiovascular Systems Corp II May-11-2012

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