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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 52
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 20
Break 18
Device alarm system issue 16
Self-activation or keying 16
Inaccurate delivery 16
Burn of device or device component 13
Charred 9
Spark 7
Unable to obtain readings 6
Bent 6
Melted 4
Programming issue 4
Improper flow or infusion 3
Overheating of device or device component 3
Automatic injection system overinfusion 3
Shock, electrical 2
Electrical issue 2
Fail-safe design failure 2
Filling problem 2
Particulates 2
Injector system failure, overinfusion of 2
Kinked 2
Program, failure to 2
Pumping stopped 2
Component missing 2
Human-Device Interface Issue 2
Battery issue 2
Power source issue 2
No Information 2
No code available 2
Naturally worn 2
Volume accuracy issue 2
Slippage of device or device component 2
Smoking 2
Material separation 1
Inappropriate shock 1
Improper or incorrect procedure or method 1
Underdelivery 1
Cut in material 1
Material perforation 1
Invalid sensing 1
Bubble detector, failure of 1
Temperature issue 1
Connection issue 1
Electrical power problem 1
Application program issue 1
Issue with displayed error message 1
Accuracy rate 1
Difficult to Program or Calibrate 1
Receiver stimulator unit, failure of 1
Mechanical issue 1
Instruction for use issue 1
Inaccurate flowrate 1
Foreign material 1
Hole in material 1
Component(s), broken 1
Deprimed 1
Low audible alarm 1
Air leak 1
Alarm, audible 1
Total Device Problems 1812

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 0 1 0 2 2 1 0 1 3 2
Class III 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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