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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 122
Pumping issue 92
Leak 88
Pumping stopped 87
Device displays error message 78
Fluid leak 73
Device operates differently than expected 46
Battery issue 37
Power source issue 30
No flow 21
Disconnection 21
Overheating of device or device component 20
Other (for use when an appropriate device code cannot be identified) 17
No display or display failure 16
Use of Device Issue 16
Battery failure 16
Device stops intermittently 16
Noise 16
Infusion or flow issue 15
Malfunction 15
Sensor problems 14
Break 13
Insufficient flow or underinfusion 12
No Known Device Problem 12
Failure to pump 11
Improper flow or infusion 11
Low battery 10
Battery charger, defective 10
Suction issue 9
Electrical issue 9
Failure to run on portable mode 8
Cable, defective 7
Out-of-box failure 7
Device Issue 7
Crack 7
Foreign material present in device 6
Failure to charge 6
Decreased pump speed 6
Device inoperable 6
Bubble(s) 5
Improper or incorrect procedure or method 5
Failure to prime 5
Motor failure 5
Loose 5
Air leak 5
Material separation 5
No device output 5
Restricted flowrate 5
Device alarm system issue 4
Failure to power-up 4
Alarm not visible 4
Detachment of device component 4
Fracture 4
Decoupling 4
Inaccurate flowrate 4
Failure to Adhere or Bond 3
Performance 3
Alarm, audible 3
Alarm system, failure of message-battery status 3
Material deformation 2
Loss of power 2
Protective measure issue 2
Burn of device or device component 2
Loose or intermittent connection 2
Meter failure 2
Packaging issue 2
Detachment of device or device component 2
Mechanical issue 2
Component(s), broken 2
Communication or transmission issue 2
Deprimed 2
Pre or post-pumping problem 2
Defective component 2
Charging issue 2
Material integrity issue 2
Heat 2
Incorrect measurement 2
Premature discharge of battery 2
Replace 2
Coagulation in device or device ingredient 2
Increase in pressure 1
Failure, intermittent 1
Connection issue 1
Sediment, precipitate or deposit in device or device ingredient 1
Device Difficult to Setup or Prepare 1
Not audible alarm 1
Particulates 1
Resistance, loss of 1
No code available 1
Issue with displayed error message 1
Corrosion 1
Product quality issue 1
Improper device output 1
Device ingredient or reagent issue 1
False alarm 1
False reading from device non-compliance 1
Failure to sense 1
Measurement system incompatibility 1
Nonstandard device or device component 1
Shelf life exceeded 1
Total Device Problems 1160

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 0
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 Jul-11-2014
9 Terumo Cardiovascular Systems Corporation II Oct-11-2012
10 Terumo Cardiovascular Systems Corporation II Oct-11-2012
11 Terumo Cardiovascular Systems Corporation II Dec-17-2009

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