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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description Nonroller-type blood pump.
Product CodeKFM
Regulation Number 870.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ABIOMED
  SUBSTANTIALLY EQUIVALENT 4
A-MED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDIAC ASSIST DIV.
  SUBSTANTIALLY EQUIVALENT 2
COBE INC.
  SUBSTANTIALLY EQUIVALENT 2
DIDECO
  SUBSTANTIALLY EQUIVALENT 2
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOPHYSICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
JOSTRA
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFEBRIDGE MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Noise, Audible 133
Pumping issue 94
Leak 90
Pumping stopped 89
Device displays error message 78
Fluid leak 73
Device operates differently than expected 43
Battery issue 37
Power source issue 32
No display or display failure 22
Overheating of device or device component 21
No flow 21
Disconnection 20
Infusion or flow issue 19
Device stops intermittently 19
Other (for use when an appropriate device code cannot be identified) 17
Use of Device Issue 16
Noise 16
Battery failure 16
Malfunction 15
No Known Device Problem 15
Sensor problems 14
Break 13
Insufficient flow or underinfusion 12
Improper flow or infusion 11
Failure to pump 11
Battery charger, defective 10
Low battery 10
Suction issue 9
Electrical issue 9
Crack 8
Failure to run on portable mode 8
Device Issue 8
Cable, defective 7
Out-of-box failure 7
Foreign material present in device 7
Device inoperable 6
Decreased pump speed 6
Air leak 6
Failure to charge 6
Bubble(s) 5
Restricted flowrate 5
Failure to prime 5
Loose 5
Motor failure 5
Improper or incorrect procedure or method 5
Material separation 5
No device output 4
Fracture 4
Failure to power-up 4
Inaccurate flowrate 4
Decoupling 4
Detachment of device component 4
Device alarm system issue 4
Alarm not visible 4
Failure to Adhere or Bond 3
Alarm, audible 3
Loss of power 3
Performance 3
Alarm system, failure of message-battery status 3
Device damaged prior to use 2
Defective component 2
Meter failure 2
Charging issue 2
Detachment of device or device component 2
Protective measure issue 2
Packaging issue 2
Material deformation 2
Material integrity issue 2
Incorrect measurement 2
Mechanical issue 2
Loose or intermittent connection 2
Heat 2
Pre or post-pumping problem 2
Replace 2
Burn of device or device component 2
Premature discharge of battery 2
Coagulation in device or device ingredient 2
Component(s), broken 2
Deprimed 2
Incorrect display 1
Failure, intermittent 1
False reading from device non-compliance 1
Failure to conduct 1
Corrosion 1
Decrease in suction 1
Failure to deploy 1
Blockage within device or device component 1
Device clogged 1
Carbon absorption 1
False alarm 1
Not audible alarm 1
Failure to run on AC/DC 1
Resistance, loss of 1
Incorrect or inadequate result 1
Failure to sense 1
Product quality issue 1
Unable to obtain readings 1
Device Difficult to Setup or Prepare 1
Decrease in pressure 1
Total Device Problems 1196

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

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. II Sep-07-2010
2 Levitronix, Llc I Jul-23-2008
3 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
4 Sorin Group USA, Inc. II Jan-14-2012
5 Sorin Group USA, Inc. II Nov-13-2009
6 Terumo Cardiovascular Corporation II Sep-28-2010
7 Terumo Cardiovascular Systems Corp II Mar-14-2007
8 Terumo Cardiovascular Systems Corporation II Feb-22-2017
9 Terumo Cardiovascular Systems Corporation II Jul-11-2014
10 Terumo Cardiovascular Systems Corporation II Oct-11-2012
11 Terumo Cardiovascular Systems Corporation II Oct-11-2012
12 Terumo Cardiovascular Systems Corporation II Dec-17-2009

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