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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 88
Device displays error message 78
Fluid leak 73
Device operates differently than expected 46
Battery issue 37
Power source issue 31
No flow 21
Disconnection 21
Overheating of device or device component 21
No display or display failure 18
Device stops intermittently 17
Other (for use when an appropriate device code cannot be identified) 17
Noise 16
Use of Device Issue 16
Battery failure 16
Malfunction 15
Infusion or flow issue 15
No Known Device Problem 14
Sensor problems 14
Break 13
Insufficient flow or underinfusion 12
Improper flow or infusion 11
Failure to pump 11
Low battery 10
Battery charger, defective 10
Electrical issue 9
Suction issue 9
Crack 8
Failure to run on portable mode 8
Cable, defective 7
Out-of-box failure 7
Device Issue 7
Device inoperable 6
Foreign material present in device 6
Decreased pump speed 6
Failure to charge 6
Bubble(s) 5
Air leak 5
Restricted flowrate 5
Failure to prime 5
Material separation 5
Motor failure 5
No device output 5
Loose 5
Improper or incorrect procedure or method 5
Failure to power-up 4
Inaccurate flowrate 4
Fracture 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
Performance 3
Alarm system, failure of message-battery status 3
Replace 2
Pre or post-pumping problem 2
Incorrect measurement 2
Mechanical issue 2
Loose or intermittent connection 2
Heat 2
Deprimed 2
Loss of power 2
Burn of device or device component 2
Premature discharge of battery 2
Coagulation in device or device ingredient 2
Component(s), broken 2
Meter failure 2
Device damaged prior to use 2
Defective component 2
Detachment of device or device component 2
Charging issue 2
Communication or transmission issue 2
Packaging issue 2
Material deformation 2
Material integrity issue 2
Protective measure issue 2
Pressure issue 1
Sediment, precipitate or deposit in device or device ingredient 1
Temperature issue 1
No Information 1
No code available 1
Measurement system incompatibility 1
Issue with displayed error message 1
Maintenance does not comply to manufacturers recommendations 1
Manufacturing or shipping issue associated with device 1
Connection issue 1
Sharp/jagged/rough/etched/scratched 1
Device ingredient or reagent issue 1
Device markings issue 1
Device misassembled during manufacturing or shipping 1
Improper device output 1
Bubble detector, failure of 1
Seal, defective 1
Incomplete or missing packaging 1
Material perforation 1
Total Device Problems 1170

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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