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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, enteral
Regulation Description Infusion pump.
Product CodeLZH
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  1
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  1
  SUBSTANTIALLY EQUIVALENT 1
ROSS PRODUCT DIV. ABBOTT LABORATORIES
  1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
ZEVEX
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 1661
Underdelivery 136
Failure to prime 134
Insufficient flow or underinfusion 78
Overdelivery 38
Excess flow or overinfusion 37
Other (for use when an appropriate device code cannot be identified) 36
Loss of power 35
Infusion or flow issue 32
Failure to auto stop 27
Device alarm system issue 27
Protective measure issue 26
Defective Alarm 19
Melted 18
Break 16
Electrical issue 15
Inaccurate delivery 14
Power source issue 13
Failure to deliver 10
Arcing 9
Component missing 8
No Information 8
Low battery 7
Smoking 6
Fire 6
False alarm 6
Cut in material 5
Fail-safe mechanism issue 5
Battery issue 5
Free or unrestricted flow 4
Failure to infuse 4
Pumping stopped 4
Alarm, audible 4
Not audible alarm 4
Burn of device or device component 3
Loose or intermittent connection 3
No display or display failure 3
Device displays error message 3
Implant Mobility NOS (Not otherwise specified) 3
Inadequate lighting 3
No Known Device Problem 3
Device operates differently than expected 2
Spark 2
Failure to fire 2
Overheating of device or device component 2
Motor drive unit (MDU) stalled or jammed 2
Use of Device Issue 2
Volume accuracy issue 2
Blockage within device or device component 2
Shock, electrical 2
Alarm not visible 2
Adaptor, failure of 2
Balloon rupture 1
Battery failure 1
Blank screen 1
Failure to charge 1
Charred 1
Compatibility 1
Use of Incorrect Control Settings 1
Crack 1
Disconnection 1
Fail-safe design failure 1
Incorrect display 1
Alarm, failure of low flow 1
Mechanical issue 1
Motor failure 1
Fluid leak 1
Image display error 1
Leak 1
Improper or incorrect procedure or method 1
Device inoperable 1
Prompts will not clear 1
Tube(s), defective 1
Occlusion within device 1
Failure to power-up 1
Device remains activated 1
Failure to pump 1
Applicator failure 1
Fuse, blown 1
Electrical power problem 1
Expulsion 1
Blocked connection 1
Charging issue 1
Inappropriate or unexpected reset 1
Pumping issue 1
Reset issue 1
Not Applicable 1
Issue with displayed error message 1
Material deformation 1
Naturally worn 1
No code available 1
Total Device Problems 2539

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Sep-20-2008
2 Abbott Nutrition, Abbott Laboratories II Sep-21-2009
3 CORPAK MedSystems II Oct-25-2011
4 MOOG Medical Devices Group II Jan-31-2013
5 MOOG Medical Devices Group II Nov-15-2012
6 Medtronic II May-10-2016
7 Ross Products Division Abbott Laboratories II Aug-08-2007
8 Ross Products Division Abbott Laboratories II Aug-07-2007
9 Zevex International, Inc. II Sep-21-2009

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