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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 91
Pumping issue 90
Leak 88
Pumping stopped 85
Device displays error message 73
Fluid leak 72
Device operates differently than expected 45
Battery issue 37
Power source issue 28
No flow 20
Disconnection 20
Overheating of device or device component 20
Other (for use when an appropriate device code cannot be identified) 17
Use of Device Issue 16
Noise 16
Battery failure 16
Device stops intermittently 15
Malfunction 15
Sensor problems 14
No display or display failure 14
Infusion or flow issue 13
Break 12
Failure to pump 11
Insufficient flow or underinfusion 11
Improper flow or infusion 11
No Known Device Problem 10
Low battery 10
Battery charger, defective 10
Electrical issue 9
Suction issue 9
Failure to run on portable mode 8
Crack 7
Device Issue 7
Cable, defective 7
Device inoperable 6
Foreign material present in device 6
Failure to charge 6
Decreased pump speed 6
Failure to prime 5
Material separation 5
Motor failure 5
No device output 5
Loose 5
Bubble(s) 5
Air leak 5
Restricted flowrate 5
Out-of-box failure 5
Improper or incorrect procedure or method 5
Inaccurate flowrate 4
Detachment of device component 4
Alarm not visible 4
Failure to power-up 4
Alarm system, failure of message-battery status 3
Performance 3
Failure to Adhere or Bond 3
Alarm, audible 3
Device alarm system issue 3
Decoupling 3
Fracture 3
Coagulation in device or device ingredient 2
Component(s), broken 2
Burn of device or device component 2
Premature discharge of battery 2
Loss of power 2
Deprimed 2
Incorrect measurement 2
Mechanical issue 2
Loose or intermittent connection 2
Heat 2
Replace 2
Pre or post-pumping problem 2
Meter failure 2
Charging issue 2
Detachment of device or device component 2
Packaging issue 2
Material integrity issue 2
Protective measure issue 2
Pressure issue 1
Measurement system incompatibility 1
Sediment, precipitate or deposit in device or device ingredient 1
Temperature issue 1
No code available 1
Device ingredient or reagent issue 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Communication or transmission issue 1
Connection issue 1
Improper device output 1
Sharp/jagged/rough/etched/scratched 1
Issue with displayed error message 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Incomplete or missing packaging 1
Material perforation 1
Defective component 1
Bubble detector, failure of 1
Seal, defective 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
User used incorrect product for intended use 1
Total Device Problems 1097

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