• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 374
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 51
Loss of power 49
Use of Device Issue 46
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
Break 18
No Known Device Problem 18
Inaccurate delivery 16
Self-activation or keying 16
Device alarm system issue 16
Burn of device or device component 12
Charred 9
Spark 7
Bent 6
Unable to obtain readings 6
Melted 4
Overheating of device or device component 3
Automatic injection system overinfusion 3
Improper flow or infusion 3
Programming issue 3
Power source issue 2
No Information 2
No code available 2
Human-Device Interface Issue 2
Naturally worn 2
Battery issue 2
Component missing 2
Slippage of device or device component 2
Smoking 2
Volume accuracy issue 2
Shock, electrical 2
Electrical issue 2
Fail-safe design failure 2
Particulates 2
Injector system failure, overinfusion of 2
Kinked 2
Program, failure to 2
Pumping stopped 2
Accuracy rate 1
Receiver stimulator unit, failure of 1
Material separation 1
Mechanical issue 1
Instruction for use issue 1
Difficult to Program or Calibrate 1
Filling problem 1
Foreign material 1
Hole in material 1
Air leak 1
Alarm, audible 1
Component(s), broken 1
Deprimed 1
Improper or incorrect procedure or method 1
Material perforation 1
Invalid sensing 1
Bubble detector, failure of 1
Underdelivery 1
Cut in material 1
Connection issue 1
Electrical power problem 1
Application program issue 1
Issue with displayed error message 1
Temperature issue 1
Total Device Problems 1799

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 0
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 Apr-23-2015
3 Hospira Inc. II Aug-06-2008
4 Hospira, Inc. II Sep-10-2012
5 Smiths Medical ASD, Inc. II Jun-18-2015
6 Smiths Medical ASD, Inc. II Nov-01-2014
7 Smiths Medical ASD, Inc. II Oct-04-2011
8 Smiths Medical ASD, Inc. II Feb-03-2011
9 Smiths Medical ASD, Inc. II Mar-11-2010
10 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010

-
-