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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, pca
Regulation Description Infusion pump.
Product CodeMEA
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
GRASEBY MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARVARD CLINICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SMITHS
  SUBSTANTIALLY EQUIVALENT 3
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 377
Failure to deliver 218
Failure to sense 173
Occlusion within device 167
Not audible alarm 144
Device inoperable 144
Device displays error message 70
Excess flow or overinfusion 55
Loss of power 49
Use of Device Issue 47
Incorrect software programming calculations 45
Insufficient flow or underinfusion 43
Overdelivery 30
Unknown (for use when the device problem is not known) 24
Failure to pump 21
No Known Device Problem 21
Break 18
Inaccurate delivery 16
Device alarm system issue 16
Self-activation or keying 16
Burn of device or device component 13
Charred 9
Spark 7
Bent 6
Unable to obtain readings 6
Programming issue 4
Melted 4
Automatic injection system overinfusion 3
Overheating of device or device component 3
Improper flow or infusion 3
Naturally worn 2
Pumping stopped 2
No Information 2
Slippage of device or device component 2
Filling problem 2
Volume accuracy issue 2
Kinked 2
Program, failure to 2
Fail-safe design failure 2
Shock, electrical 2
No code available 2
Smoking 2
Component missing 2
Particulates 2
Electrical issue 2
Human-Device Interface Issue 2
Battery issue 2
Power source issue 2
Injector system failure, overinfusion of 2
Improper or incorrect procedure or method 1
Inaccurate flowrate 1
Issue with displayed error message 1
Inappropriate shock 1
Foreign material 1
Alarm, audible 1
Deprimed 1
Electrical power problem 1
Difficult to Program or Calibrate 1
Connection issue 1
Invalid sensing 1
Material separation 1
Hole in material 1
Accuracy rate 1
Application program issue 1
Air leak 1
Bubble detector, failure of 1
Underdelivery 1
Receiver stimulator unit, failure of 1
Temperature issue 1
Mechanical issue 1
Component(s), broken 1
Instruction for use issue 1
Cut in material 1
Material perforation 1
Low audible alarm 1
Total Device Problems 1816

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 2 2 1 0 1 3 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Apr-27-2015
2 Hospira Inc. II Sep-22-2016
3 Hospira Inc. II Jul-08-2016
4 Hospira Inc. II Apr-23-2015
5 Hospira Inc. II Aug-06-2008
6 Hospira, Inc. II Sep-10-2012
7 Smiths Medical ASD, Inc. II Jun-18-2015
8 Smiths Medical ASD, Inc. II Nov-01-2014
9 Smiths Medical ASD, Inc. II Oct-04-2011
10 Smiths Medical ASD, Inc. II Feb-03-2011
11 Smiths Medical ASD, Inc. II Mar-11-2010
12 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010

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