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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 2
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 4

Device Problems
Other (for use when an appropriate device code cannot be identified) 716
Device displays error message 551
Malfunction 516
Pumping stopped 501
Device operates differently than expected 453
No display or display failure 295
Sensor problems 265
Monitor failure 256
Break 179
Device alarm system issue 130
Battery charger, defective 126
Failure to power-up 126
Failure to calibrate 124
Battery issue 117
Battery failure 116
Gas delivery system failure 102
Fracture 92
False alarm 88
Fluid leak 78
Leak 78
Incorrect display 76
Ambient noise issue 68
Component missing 68
Power source issue 67
Detachment of device component 67
Performance 67
Noise 61
Calibration error 60
Device stops intermittently 59
Occlusion within device 57
Loss of power 56
Occlusion, incorrect 55
Failure to pump 46
Crack 43
Mechanical issue 42
Loose or intermittent connection 41
Decreased pump speed 35
Increased pump speed 35
Computer failure 35
Device inoperable 34
Alarm, audible 30
Component(s), broken 30
Failure to run on portable mode 30
Mechanical jam 28
No flow 27
Protective measure issue 27
Calibration issue 26
Failure to charge 26
Defective component 23
Naturally worn 23
Difficult to open or close 21
Failure to Adhere or Bond 21
Pre or post-pumping problem 21
Corrosion 20
Output issue 20
No Known Device Problem 19
Device sensing issue 19
Improper flow or infusion 19
Out-of-box failure 19
Bent 19
Unable to obtain readings 18
Failure to run on AC/DC 17
Use of Incorrect Control Settings 17
Alarm system, failure of message-battery status 17
Material separation 17
Infusion or flow issue 17
Improper alarm 16
Pumping issue 16
Charging issue 16
Connection issue 15
Erratic display 15
Incorrect or inadequate result 14
Use of Device Issue 14
Problem with software installation 14
Material deformation 14
Positioning Issue 13
False reading from device non-compliance 13
Alarm not visible 13
Circuit Failure 13
Slippage of device or device component 12
Detachment of device or device component 11
Communication or transmission issue 11
Cut in material 11
Pressure issue 11
Inaccurate flowrate 11
Electrical issue 11
Artifact 10
Loss of or failure to bond 10
Maintenance does not comply to manufacturers recommendations 10
No Information 10
Material integrity issue 10
Torn material 9
Device Issue 9
Smoking 9
Not audible alarm 9
Degraded 9
Sensing intermittently 9
Failure to sense 9
Peeled 9
Improper gas output 9
Total Device Problems 6947

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 15 7 3 2 10 23 7 3 2 1
Class III 3 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
2 Maquet Cardiovascular Us Sales, Llc II May-28-2015
3 Maquet Cardiovascular Us Sales, Llc II Nov-13-2014
4 Maquet Cardiovascular Us Sales, Llc II Feb-22-2011
5 Maquet Cardiovascular, LLC II Apr-18-2013
6 Maquet Inc. II Aug-29-2011
7 Maquet Inc. II Aug-22-2011
8 Maquet Medical Systems USA II Oct-25-2013
9 Medtronic Perfusion Systems II Jul-23-2007
10 Salyer Prn Biomedical II Mar-01-2013
11 Sorin Group Deutschland GmbH II Jan-28-2014
12 Sorin Group Deutschland GmbH II Nov-04-2013
13 Sorin Group Deutschland GmbH II Mar-29-2012
14 Sorin Group USA, Inc. II Nov-08-2012
15 Sorin Group USA, Inc. II Mar-05-2012
16 Sorin Group USA, Inc. II Jan-26-2011
17 Sorin Group USA, Inc. II Jul-22-2010
18 Terumo Cardiovascular Systems Corp II Dec-01-2007
19 Terumo Cardiovascular Systems Corp II Dec-01-2007
20 Terumo Cardiovascular Systems Corp II Jul-07-2007
21 Terumo Cardiovascular Systems Corp III Jun-30-2007
22 Terumo Cardiovascular Systems Corp II Jun-30-2007
23 Terumo Cardiovascular Systems Corp III Jun-30-2007
24 Terumo Cardiovascular Systems Corp II Jun-30-2007
25 Terumo Cardiovascular Systems Corp III Jun-30-2007
26 Terumo Cardiovascular Systems Corp II Jun-30-2007
27 Terumo Cardiovascular Systems Corp II Feb-14-2007
28 Terumo Cardiovascular Systems Corp II Feb-14-2007
29 Terumo Cardiovascular Systems Corp II Feb-14-2007
30 Terumo Cardiovascular Systems Corp II Feb-14-2007
31 Terumo Cardiovascular Systems Corp II Feb-14-2007
32 Terumo Cardiovascular Systems Corp II Feb-14-2007
33 Terumo Cardiovascular Systems Corp II Feb-01-2007
34 Terumo Cardiovascular Systems Corp II Jan-09-2007
35 Terumo Cardiovascular Systems Corporation II May-28-2015
36 Terumo Cardiovascular Systems Corporation II Jul-08-2014
37 Terumo Cardiovascular Systems Corporation II Aug-15-2013
38 Terumo Cardiovascular Systems Corporation II Aug-14-2013
39 Terumo Cardiovascular Systems Corporation II Aug-14-2013
40 Terumo Cardiovascular Systems Corporation II Nov-27-2012
41 Terumo Cardiovascular Systems Corporation II Nov-13-2012
42 Terumo Cardiovascular Systems Corporation II Oct-24-2012
43 Terumo Cardiovascular Systems Corporation II Sep-25-2012
44 Terumo Cardiovascular Systems Corporation II Sep-24-2012
45 Terumo Cardiovascular Systems Corporation II Sep-11-2012
46 Terumo Cardiovascular Systems Corporation II Aug-21-2012
47 Terumo Cardiovascular Systems Corporation III Aug-16-2012
48 Terumo Cardiovascular Systems Corporation II Aug-09-2012
49 Terumo Cardiovascular Systems Corporation II Jul-20-2012
50 Terumo Cardiovascular Systems Corporation II Jul-19-2012
51 Terumo Cardiovascular Systems Corporation II Jul-17-2012
52 Terumo Cardiovascular Systems Corporation II Jul-13-2012
53 Terumo Cardiovascular Systems Corporation II Jul-09-2012
54 Terumo Cardiovascular Systems Corporation II Jul-09-2012
55 Terumo Cardiovascular Systems Corporation II Jul-09-2012
56 Terumo Cardiovascular Systems Corporation II Jul-09-2012
57 Terumo Cardiovascular Systems Corporation II Jul-06-2012
58 Terumo Cardiovascular Systems Corporation II Apr-23-2012
59 Terumo Cardiovascular Systems Corporation II Mar-27-2012
60 Terumo Cardiovascular Systems Corporation II Jan-24-2012
61 Terumo Cardiovascular Systems Corporation II Nov-29-2011
62 Terumo Cardiovascular Systems Corporation II Nov-29-2011
63 Terumo Cardiovascular Systems Corporation II Jul-06-2011
64 Terumo Cardiovascular Systems Corporation II Jun-22-2011
65 Terumo Cardiovascular Systems Corporation II Mar-07-2011
66 Terumo Cardiovascular Systems Corporation II Jan-07-2011
67 Terumo Cardiovascular Systems Corporation II Sep-23-2010
68 Terumo Cardiovascular Systems Corporation II May-29-2009
69 Terumo Cardiovascular Systems Corporation II Feb-24-2009
70 Terumo Cardiovascular Systems Corporation II Jan-29-2009
71 Terumo Cardiovascular Systems Corporation II Dec-29-2008
72 Terumo Cardiovascular Systems Corporation II Dec-11-2008
73 Terumo Cardiovascular Systems Corporation II Dec-10-2008
74 Terumo Cardiovascular Systems Corporation II Nov-25-2008
75 Terumo Cardiovascular Systems Corporation II Nov-07-2008
76 Terumo Cardiovascular Systems Corporation II Nov-06-2008
77 Terumo Cardiovascular Systems Corporation II Oct-31-2008

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