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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 cardiopulmonary bypass blood pump.
Product CodeKFM
Regulation Number 870.4360
Device Class 3


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 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
NOVOSCI, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Fluid leak 42
Leak 32
Disconnection 19
Battery failure 16
Noise 16
Malfunction 15
Sensor problems 14
Pumping stopped 11
Failure to pump 10
Battery charger, defective 10
Break 8
Cable, defective 7
Other (for use when an appropriate device code cannot be identified) 6
Bubble(s) 5
Crack 5
Loose 5
Motor failure 5
Decreased pump speed 4
Restricted flowrate 4
Inaccurate flowrate 4
Electrical issue 4
Device Issue 4
Out-of-box failure 3
Alarm system, failure of message-battery status 3
Material separation 3
Device displays error message 3
Improper flow or infusion 3
Device operates differently than expected 3
No display or display failure 3
Alarm, audible 3
Failure to prime 3
Performance 3
Overheating of device or device component 2
Deprimed 2
Failure to power-up 2
Heat 2
Component(s), broken 2
Foreign material present in device 2
Pumping issue 2
Replace 2
Use of Device Issue 2
Meter failure 2
Bubble detector, failure of 1
Seal, defective 1
Insufficient flow or underinfusion 1
Device inoperable 1
Resistance, loss of 1
Shelf life exceeded 1
No code available 1
Infusion or flow issue 1
Material integrity issue 1
No flow 1
Power source issue 1
Battery issue 1
Detachment of device or device component 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Detachment of device component 1
Decoupling 1
Failure, intermittent 1
False reading from device non-compliance 1
Device alarm system issue 1
Air leak 1
Device clogged 1
Coagulation in device or device ingredient 1
Difficult to insert 1
Loose or intermittent connection 1
Material fragmentation 1
Failure to run on portable mode 1
Total Device Problems 323

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 1 0 0 0 0 0
Class II 1 0 2 2 0 3 0
Class III 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 Sorin Group USA, Inc. II Jan-14-2012
4 Sorin Group USA, Inc. II Nov-13-2009
5 Terumo Cardiovascular Corporation II Sep-28-2010
6 Terumo Cardiovascular Systems Corp II Mar-14-2007
7 Terumo Cardiovascular Systems Corporation II Oct-11-2012
8 Terumo Cardiovascular Systems Corporation II Oct-11-2012
9 Terumo Cardiovascular Systems Corporation II Dec-17-2009

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