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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 767
Inaccurate flowrate 563
Filling problem 554
Infusion or flow issue 362
Material rupture 347
No flow 253
Foreign material present in device 240
Failure to infuse 193
Excess flow or overinfusion 119
Leak 96
Device operates differently than expected 79
Disconnection 69
Break 60
No Known Device Problem 59
Insufficient flow or underinfusion 40
Detachment of device component 30
Loose or intermittent connection 30
Component missing 28
Failure to deliver 19
Failure to prime 12
Material separation 11
Reflux within device 10
Crack 10
Improper or incorrect procedure or method 8
Split 8
Material deformation 7
Improper flow or infusion 6
Cut in material 6
Torn material 6
Material puncture 5
Material integrity issue 4
Unknown (for use when the device problem is not known) 3
Burst 3
Bent 3
Device Difficult to Setup or Prepare 3
Scratched material 3
No Information 2
Hole in material 2
Fracture 2
Device damaged prior to use 2
Fitting problem 2
Slippage of device or device component 2
Stretched 2
Device markings issue 2
Connection issue 2
Detachment of device or device component 1
Defective item 1
Device displays error message 1
Battery issue 1
Manufacturing or shipping issue associated with device 1
Difficult to open or close 1
Dislodged or dislocated 1
Use of Device Issue 1
Sticking 1
Electro-static discharge 1
Tube(s), defective 1
Material perforation 1
Material fragmentation 1
Kinked 1
Device, or device fragments remain in patient 1
Retraction problem 1
User used incorrect product for intended use 1
Shaft break 1
Shelf life exceeded 1
Bleed back 1
Blockage within device or device component 1
Device alarm system issue 1
Mechanical issue 1
Melted 1
Migration of device or device component 1
Misassembled 1
Misconnection 1
Particulates 1
Precipitate in device or device ingredient 1
Medication Error 1
Packaging issue 1
Pumping issue 1
Total Device Problems 4066

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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