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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 382
Failure to deliver 218
Failure to sense 173
Occlusion within device 167
Not audible alarm 145
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
No Known Device Problem 21
Failure to pump 21
Break 18
Device alarm system issue 16
Inaccurate delivery 16
Self-activation or keying 16
Burn of device or device component 13
Charred 10
Spark 7
Unable to obtain readings 6
Bent 6
Melted 4
Programming issue 4
Smoking 4
Improper flow or infusion 3
Overheating of device or device component 3
Automatic injection system overinfusion 3
Filling problem 3
Shock, electrical 2
Electrical issue 2
Fail-safe design failure 2
Particulates 2
Injector system failure, overinfusion of 2
Kinked 2
Pumping stopped 2
Component missing 2
Human-Device Interface Issue 2
Power source issue 2
Battery issue 2
Slippage of device or device component 2
Program, failure to 2
Volume accuracy issue 2
Improper or incorrect procedure or method 2
No Information 2
No code available 2
Naturally worn 2
Material separation 1
Inappropriate shock 1
Material perforation 1
Invalid sensing 1
Bubble detector, failure of 1
Charging issue 1
Connection issue 1
Electrical power problem 1
Application program issue 1
Underdelivery 1
Cut in material 1
Temperature issue 1
Issue with displayed error message 1
Accuracy rate 1
Receiver stimulator unit, failure of 1
Difficult to Program or Calibrate 1
Failure to power-up 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
No display or display failure 1
Low audible alarm 1
Air leak 1
Alarm, audible 1
Total Device Problems 1830

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 1
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 Mar-10-2017
8 Smiths Medical ASD, Inc. II Jun-18-2015
9 Smiths Medical ASD, Inc. II Nov-01-2014
10 Smiths Medical ASD, Inc. II Oct-04-2011
11 Smiths Medical ASD, Inc. II Feb-03-2011
12 Smiths Medical ASD, Inc. II Mar-11-2010
13 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010

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