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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, elastomeric
Regulation Description Infusion pump.
Product CodeMEB
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED INFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 5
APEX
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 16
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
LEVENTON, S.A.
  SUBSTANTIALLY EQUIVALENT 1
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL FLOW SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 5
SYMBIOS MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
TANDEM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VLV ASSOCIATES, INC.
  1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3
WESTMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fluid leak 729
Inaccurate flowrate 561
Filling problem 536
Infusion or flow issue 361
Material rupture 332
No flow 244
Foreign material present in device 240
Failure to infuse 188
Excess flow or overinfusion 111
Leak 91
Device operates differently than expected 79
Disconnection 66
No Known Device Problem 58
Break 57
Insufficient flow or underinfusion 40
Detachment of device component 30
Loose or intermittent connection 29
Component missing 27
Failure to deliver 18
Failure to prime 12
Material separation 11
Reflux within device 10
Crack 9
Split 8
Improper or incorrect procedure or method 8
Material deformation 7
Improper flow or infusion 6
Cut in material 6
Material puncture 5
Torn material 5
Scratched material 3
Material integrity issue 3
Unknown (for use when the device problem is not known) 3
Burst 3
Bent 3
Device Difficult to Setup or Prepare 3
Hole in material 2
Slippage of device or device component 2
Stretched 2
Fracture 2
Device damaged prior to use 2
Fitting problem 2
Device markings issue 2
Connection issue 2
No Information 2
Medication Error 1
Detachment of device or device component 1
Difficult to open or close 1
Dislodged or dislocated 1
Manufacturing or shipping issue associated with device 1
Packaging issue 1
Pumping issue 1
Electro-static discharge 1
Tube(s), defective 1
Material perforation 1
Defective item 1
Device displays error message 1
Battery issue 1
Material fragmentation 1
Mechanical issue 1
Melted 1
Migration of device or device component 1
Particulates 1
Precipitate in device or device ingredient 1
Bleed back 1
Blockage within device or device component 1
Device alarm system issue 1
Use of Device Issue 1
Sticking 1
Shaft break 1
Shelf life exceeded 1
Kinked 1
Device, or device fragments remain in patient 1
Retraction problem 1
User used incorrect product for intended use 1
Total Device Problems 3950

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

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Medical, Inc. II Sep-16-2014
2 B. Braun Medical, Inc. II Feb-03-2014
3 Baxter Healthcare Corp. II Jul-10-2013
4 Baxter Healthcare Corp. II Jun-27-2013
5 Baxter Healthcare Corp. II Jun-27-2013
6 Baxter Healthcare Corp. II May-05-2011
7 Baxter Healthcare Corp. II Jan-23-2008
8 First Medical Source LLC I Oct-30-2012
9 Hsmg, Inc. D/b/a Smartinfuser Usa II Apr-14-2011
10 Hsmg, Inc. D/b/a Smartinfuser Usa II Mar-08-2010
11 I-Flow Corporation I Aug-28-2012
12 I-Flow Corporation II Jul-28-2011
13 I-Flow Corporation II Sep-14-2009
14 I-Flow Corporation II Sep-11-2008
15 I-Flow Corporation II Sep-11-2008
16 I-Flow Corporation II Jan-18-2007
17 Progressive Medical Inc I Oct-24-2011
18 Stryker Instruments Div. of Stryker Corporation II Sep-04-2009
19 Symbios Medical Products, LLC I Jun-06-2013
20 Symbios Medical Products, LLC I Mar-13-2013
21 Victus, Inc. I Oct-24-2011
22 Wolf Medical Supply Inc. I Nov-23-2011

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