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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device console, heart-lung machine, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass heart-lung machine console.
Product CodeDTQ
Regulation Number 870.4220
Device Class 2


Premarket Reviews
ManufacturerDecision
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
LIFEBRIDGE MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAND S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SORIN
  SUBSTANTIALLY EQUIVALENT 8
STOCKERT GMBH
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Malfunction 516
Pumping stopped 387
Sensor problems 265
Monitor failure 256
Device displays error message 201
No display or display failure 199
Other (for use when an appropriate device code cannot be identified) 159
Device operates differently than expected 139
Battery charger, defective 126
Break 116
Battery failure 116
Failure to power-up 106
Gas delivery system failure 102
Fracture 88
Ambient noise issue 68
Failure to calibrate 68
Performance 67
Noise 61
Component missing 61
Occlusion within device 56
Calibration error 56
False alarm 56
Occlusion, incorrect 55
Loss of power 51
Failure to pump 44
Device alarm system issue 42
Crack 41
Battery issue 38
Detachment of device component 37
Incorrect display 36
Mechanical issue 36
Increased pump speed 35
Computer failure 35
Decreased pump speed 33
Alarm, audible 30
Component(s), broken 29
Loose or intermittent connection 24
Defective component 23
Pre or post-pumping problem 21
Naturally worn 21
Corrosion 20
Device inoperable 19
Difficult to open or close 18
Alarm system, failure of message-battery status 17
Failure to Adhere or Bond 16
Material separation 16
Use of Incorrect Control Settings 16
Unable to obtain readings 15
Leak 14
False reading from device non-compliance 12
Bent 12
Mechanical jam 12
Failure to charge 12
Output issue 12
Cut in material 11
Degraded 9
Circuit Failure 9
Pressure sensor failure 8
Failure to align 8
Delamination 8
Incorrect or inadequate result 8
Communication or transmission issue 8
Difficult to remove 8
Pressure issue 8
Peeled 8
Material deformation 7
Improper gas output 7
Torn material 7
Image orientation incorrect 7
Erratic display 6
Misassembled 6
Restricted flowrate 6
Slippage of device or device component 6
Smoking 6
Defective item 6
No flow 6
Improper flow or infusion 6
Inaccurate flowrate 6
Device sensing issue 6
Poor quality image 6
Motor failure 6
Device Issue 6
Pumping issue 6
Infusion or flow issue 6
Improper device output 5
Detachment of device or device component 5
Failure to run on AC/DC 5
Artifact 5
Free or unrestricted flow 5
Positioning Issue 5
Scratched material 5
Component falling 4
Defective Alarm 4
Cable, defective 4
Inadequate lighting 4
Unknown (for use when the device problem is not known) 4
Shipping damage or problem 4
Material puncture 4
Circuit breaker tripped 4
Decrease in pressure 4
Total Device Problems 4393

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 15 7 3 2 10 23 2
Class III 3 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Feb-22-2011
2 Maquet Cardiovascular, LLC II Apr-18-2013
3 Maquet Inc. II Aug-29-2011
4 Maquet Inc. II Aug-22-2011
5 Medtronic Perfusion Systems II Jul-23-2007
6 Salyer Prn Biomedical II Mar-01-2013
7 Sorin Group Deutschland GmbH II Mar-29-2012
8 Sorin Group USA, Inc. II Nov-08-2012
9 Sorin Group USA, Inc. II Mar-05-2012
10 Sorin Group USA, Inc. II Jan-26-2011
11 Sorin Group USA, Inc. II Jul-22-2010
12 Terumo Cardiovascular Systems Corp II Dec-01-2007
13 Terumo Cardiovascular Systems Corp II Dec-01-2007
14 Terumo Cardiovascular Systems Corp II Jul-07-2007
15 Terumo Cardiovascular Systems Corp III Jun-30-2007
16 Terumo Cardiovascular Systems Corp II Jun-30-2007
17 Terumo Cardiovascular Systems Corp III Jun-30-2007
18 Terumo Cardiovascular Systems Corp II Jun-30-2007
19 Terumo Cardiovascular Systems Corp III Jun-30-2007
20 Terumo Cardiovascular Systems Corp II Jun-30-2007
21 Terumo Cardiovascular Systems Corp II Feb-14-2007
22 Terumo Cardiovascular Systems Corp II Feb-14-2007
23 Terumo Cardiovascular Systems Corp II Feb-14-2007
24 Terumo Cardiovascular Systems Corp II Feb-14-2007
25 Terumo Cardiovascular Systems Corp II Feb-14-2007
26 Terumo Cardiovascular Systems Corp II Feb-14-2007
27 Terumo Cardiovascular Systems Corp II Feb-01-2007
28 Terumo Cardiovascular Systems Corp II Jan-09-2007
29 Terumo Cardiovascular Systems Corporation II Nov-27-2012
30 Terumo Cardiovascular Systems Corporation II Nov-13-2012
31 Terumo Cardiovascular Systems Corporation II Oct-24-2012
32 Terumo Cardiovascular Systems Corporation II Sep-25-2012
33 Terumo Cardiovascular Systems Corporation II Sep-24-2012
34 Terumo Cardiovascular Systems Corporation II Sep-11-2012
35 Terumo Cardiovascular Systems Corporation II Aug-21-2012
36 Terumo Cardiovascular Systems Corporation III Aug-16-2012
37 Terumo Cardiovascular Systems Corporation II Aug-09-2012
38 Terumo Cardiovascular Systems Corporation II Jul-20-2012
39 Terumo Cardiovascular Systems Corporation II Jul-19-2012
40 Terumo Cardiovascular Systems Corporation II Jul-17-2012
41 Terumo Cardiovascular Systems Corporation II Jul-13-2012
42 Terumo Cardiovascular Systems Corporation II Jul-09-2012
43 Terumo Cardiovascular Systems Corporation II Jul-09-2012
44 Terumo Cardiovascular Systems Corporation II Jul-09-2012
45 Terumo Cardiovascular Systems Corporation II Jul-09-2012
46 Terumo Cardiovascular Systems Corporation II Jul-06-2012
47 Terumo Cardiovascular Systems Corporation II Apr-23-2012
48 Terumo Cardiovascular Systems Corporation II Mar-27-2012
49 Terumo Cardiovascular Systems Corporation II Jan-24-2012
50 Terumo Cardiovascular Systems Corporation II Nov-29-2011
51 Terumo Cardiovascular Systems Corporation II Nov-29-2011
52 Terumo Cardiovascular Systems Corporation II Jul-06-2011
53 Terumo Cardiovascular Systems Corporation II Jun-22-2011
54 Terumo Cardiovascular Systems Corporation II Mar-07-2011
55 Terumo Cardiovascular Systems Corporation II Jan-07-2011
56 Terumo Cardiovascular Systems Corporation II Sep-23-2010
57 Terumo Cardiovascular Systems Corporation II May-29-2009
58 Terumo Cardiovascular Systems Corporation II Feb-24-2009
59 Terumo Cardiovascular Systems Corporation II Jan-29-2009
60 Terumo Cardiovascular Systems Corporation II Dec-29-2008
61 Terumo Cardiovascular Systems Corporation II Dec-11-2008
62 Terumo Cardiovascular Systems Corporation II Dec-10-2008
63 Terumo Cardiovascular Systems Corporation II Nov-25-2008
64 Terumo Cardiovascular Systems Corporation II Nov-07-2008
65 Terumo Cardiovascular Systems Corporation II Nov-06-2008
66 Terumo Cardiovascular Systems Corporation II Oct-31-2008

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