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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 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 283
Failure to deliver 147
Not audible alarm 89
Failure to sense 53
Occlusion within device 51
Incorrect software programming calculations 38
Use of Device Issue 37
Excess flow or overinfusion 32
Overdelivery 29
Insufficient flow or underinfusion 24
Unknown (for use when the device problem is not known) 21
Failure to pump 20
Self-activation or keying 15
Loss of power 13
Device alarm system issue 8
Device displays error message 8
Inaccurate delivery 7
Charred 5
No Known Device Problem 5
Break 4
Automatic injection system overinfusion 3
Spark 3
Bent 3
Programming issue 2
Shock, electrical 2
Fail-safe design failure 2
Injector system failure, overinfusion of 2
Program, failure to 2
Burn of device or device component 2
Melted 2
Improper flow or infusion 2
No Information 2
No code available 2
Pumping stopped 2
Slippage of device or device component 2
Receiver stimulator unit, failure of 1
Component missing 1
Cut in material 1
Particulates 1
Instruction for use issue 1
Mechanical issue 1
Component(s), broken 1
Underdelivery 1
Kinked 1
Volume accuracy issue 1
Difficult to Program or Calibrate 1
Improper or incorrect procedure or method 1
Issue with displayed error message 1
Material separation 1
Bubble detector, failure of 1
Alarm, audible 1
Foreign material 1
Accuracy rate 1
Total Device Problems 940

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

Recalls
Manufacturer Recall Class Date Posted
1 Hospira Inc. II Aug-06-2008
2 Hospira, Inc. II Sep-10-2012
3 Smiths Medical ASD, Inc. II Oct-04-2011
4 Smiths Medical ASD, Inc. II Feb-03-2011
5 Smiths Medical ASD, Inc. II Mar-11-2010
6 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010

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