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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 500
Inaccurate flowrate 462
Filling problem 377
Infusion or flow issue 358
Material rupture 222
Foreign material present in device 216
No flow 152
Failure to infuse 140
Excess flow or overinfusion 106
Device operates differently than expected 78
Leak 63
No Known Device Problem 55
Disconnection 50
Insufficient flow or underinfusion 37
Break 31
Detachment of device component 30
Loose or intermittent connection 26
Failure to deliver 16
Component missing 15
Material separation 10
Reflux within device 8
Failure to prime 8
Split 8
Improper or incorrect procedure or method 6
Improper flow or infusion 6
Material deformation 6
Torn material 5
Cut in material 4
Material puncture 4
Crack 4
Burst 3
Bent 3
Device Difficult to Setup or Prepare 3
Unknown (for use when the device problem is not known) 3
Scratched material 3
No Information 2
Device damaged prior to use 2
Fitting problem 2
Stretched 2
Device markings issue 2
Connection issue 2
Slippage of device or device component 2
Fracture 2
Material fragmentation 1
Hole in material 1
Kinked 1
Bleed back 1
Blockage within device or device component 1
Device alarm system issue 1
Sticking 1
Device, or device fragments remain in patient 1
Shaft break 1
Shelf life exceeded 1
User used incorrect product for intended use 1
Mechanical issue 1
Melted 1
Migration of device or device component 1
Particulates 1
Precipitate in device or device ingredient 1
Detachment of device or device component 1
Device displays error message 1
Battery issue 1
Use of Device Issue 1
Tube(s), defective 1
Medication Error 1
Manufacturing or shipping issue associated with device 1
Difficult to open or close 1
Dislodged or dislocated 1
Packaging issue 1
Pumping issue 1
Total Device Problems 3061

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