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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion
Regulation Description Infusion pump.
Product CodeFRN
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 8
ABBOTT
  SUBSTANTIALLY EQUIVALENT 69
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SE SUBJECT TO TRACKING REG 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 12
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 41
BELMONT INSTRUMENT CORP.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 3
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 22
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 8
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 6
  1.  K043590  SE INFUSION SYSTEM WITH MMS
  2.  K051641  ALARIS SYSTEM PC UNIT, MODEL 8001
  3.  K063288  SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
  4.  K070268  SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 72 ...
  5.  K072105  ALARIS SYSTEM WITH MMS, MODEL 8XXX
  6.  K091308  ALARIS PC UNIT, MODELS 8000 AND 8015
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELPHI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DISETRONIC MEDICAL SYSTEMS, INC.
  SE SUBJECT TO TRACKING REG 3
  SUBSTANTIALLY EQUIVALENT 5
ELIXIR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLUIDSENSE CORP
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRASEBY MEDICAL LTD.
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 6
HARVARD CLINICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 9
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 13
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 22
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 7
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 3
MEDEX
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 4
MEDFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
METTLER ELECTRONICS CORP.
  SE SUBJECT TO TRACKING REG 1
MINNESOTA MINING AND MFG. CO.
  SE SUBJECT TO TRACKING REG 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q-CORE, LTD
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SABRATEK
  SUBSTANTIALLY EQUIVALENT 4
SIGMA
  SUBSTANTIALLY EQUIVALENT 6
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 12
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 7
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Component(s), broken 2454
Battery failure 1698
Device displays error message 1608
Device inoperable 852
Not audible alarm 748
Defective component 672
Excess flow or overinfusion 614
Failure to deliver 533
Failure to sense 376
Alarm, audible 334
Insufficient flow or underinfusion 314
Inaccurate flowrate 280
Break 273
Fluid leak 243
Overdelivery 234
Occlusion within device 228
Infusion or flow issue 192
Device alarm system issue 185
Underdelivery 140
Device operates differently than expected 138
Use of Device Issue 135
Loss of power 125
Bent 121
Spark 106
Incorrect software programming calculations 94
Charred 88
Inaccurate delivery 85
Calibration error 83
Material separation 82
Free or unrestricted flow 72
Improper flow or infusion 65
Pressure sensor failure 63
Bubble detector, failure of 61
Air leak 59
Self-activation or keying 57
Malfunction 53
Reflux within device 46
Unknown (for use when the device problem is not known) 43
Melted 38
Calibration issue 37
Pumping stopped 36
Smoking 36
Failure to power-up 36
Accuracy rate 32
Burn of device or device component 32
No Known Device Problem 31
Sticking 31
Other (for use when an appropriate device code cannot be identified) 30
Disconnection 28
Defective Alarm 26
Failure to infuse 26
Battery issue 24
False alarm 24
Sensor problems 24
Fire 23
Electrical issue 19
Material rupture 16
Slippage of device or device component 15
Device stops intermittently 14
Shock, electrical 13
Pumping issue 13
Failure to prime 12
Leak 12
Computer software issue 11
Restricted flowrate 10
Valve(s), failure of 10
Particulates 10
Mechanical issue 10
Crack 9
Size incorrect for patient 9
Volume accuracy issue 9
Inappropriate prompts 8
Incorrect display 7
Increased pump speed 7
Failure to pump 7
Component missing 6
Defective item 6
Deployment issue 6
No Information 6
Delivery system failure 5
Hole in material 5
Use of Incorrect Control Settings 4
Failure to calibrate 4
Failure to shut off 4
No display or display failure 4
Improper or incorrect procedure or method 4
Foreign material present in device 4
Arcing 3
Poor quality image 3
Blank screen 3
Overheating of device or device component 3
No flow 3
Not Applicable 3
Failure to deploy 3
Programming issue 3
Tears, rips, holes in device, device material 3
Device Issue 3
Circuit Failure 3
Low battery 3
Device markings issue 2
Total Device Problems 14385

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 3 1 2 7 4 8 3
Class II 6 9 10 9 20 14 3
Class III 1 0 0 0 1 2 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, INC II Nov-17-2010
2 B Braun Medical, Inc I Oct-18-2011
3 B Braun Medical, Inc II Oct-03-2011
4 B Braun Medical, Inc I Jan-10-2011
5 B. Braun Medical, Inc. II Dec-31-2012
6 B. Braun Medical, Inc. I Jul-16-2012
7 B. Braun Medical, Inc. I Feb-29-2012
8 B. Braun Medical, Inc. II Sep-23-2008
9 Baxter Healthcare Corp. III Aug-24-2012
10 Baxter Healthcare Corp. II Jan-13-2012
11 Baxter Healthcare Corp. II Jan-11-2012
12 Baxter Healthcare Corp. II Oct-28-2011
13 Baxter Healthcare Corp. II Aug-11-2011
14 Baxter Healthcare Corp. II Aug-11-2011
15 Baxter Healthcare Corp. II Aug-08-2011
16 Baxter Healthcare Corp. II Jul-19-2011
17 Baxter Healthcare Corp. II Jul-13-2011
18 Baxter Healthcare Corp. II May-19-2011
19 Baxter Healthcare Corp. II Apr-29-2011
20 Baxter Healthcare Corp. III Feb-18-2011
21 Baxter Healthcare Corp. II Jan-21-2011
22 Baxter Healthcare Corp. II Jan-21-2011
23 Baxter Healthcare Corp. II Jan-21-2011
24 Baxter Healthcare Corp. I Oct-12-2010
25 Baxter Healthcare Corp. I Mar-02-2009
26 Baxter Healthcare Corp. II Oct-21-2008
27 Baxter Healthcare Corp. I Sep-19-2007
28 Baxter Healthcare Corp. I Jul-28-2007
29 Baxter Healthcare Corp. I Jul-18-2007
30 Baxter Healthcare Corp. II Mar-20-2007
31 Baxter Healthcare Corp. II Jan-11-2007
32 Belmont Instrument Corporation II Oct-12-2012
33 Cardinal Health 303 Inc DBA Alaris Products II Jun-10-2008
34 Cardinal Health 303 Inc DBA Alaris Products I Jan-04-2008
35 Cardinal Health 303 Inc DBA Alaris Products II Aug-03-2007
36 Cardinal Health 303 Inc DBA Alaris Products II Aug-02-2007
37 Cardinal Health 303 dba Cardinal Health I Aug-03-2009
38 Cardinal Health 303 dba Cardinal Health II May-01-2009
39 Cardinal Health 303 dba Cardinal Health II Apr-07-2009
40 CareFusion 303, Inc. I Aug-17-2012
41 CareFusion 303, Inc. I Aug-15-2012
42 CareFusion 303, Inc. I Jul-26-2012
43 CareFusion 303, Inc. II Jan-26-2012
44 CareFusion Corporation I Oct-13-2010
45 Carefusion Corporation I Apr-15-2013
46 Carefusion Corporation II Apr-15-2013
47 Curlin Medical Llc II Sep-22-2008
48 Hospira Inc II Mar-08-2011
49 Hospira Inc I Oct-22-2010
50 Hospira Inc II Sep-09-2010
51 Hospira Inc I Sep-08-2010
52 Hospira Inc I Jul-02-2010
53 Hospira Inc II Oct-06-2009
54 Hospira Inc II Aug-11-2009
55 Hospira Inc II Feb-27-2009
56 Hospira Inc. I Apr-30-2013
57 Hospira Inc. I Apr-26-2013
58 Hospira Inc. II Apr-15-2013
59 Hospira Inc. II Dec-31-2012
60 Hospira Inc. II Dec-07-2012
61 Hospira Inc. I Oct-19-2012
62 Hospira Inc. II May-04-2012
63 Hospira Inc. II Apr-26-2012
64 Hospira Inc. II Oct-04-2011
65 Hospira Inc. II Sep-29-2011
66 Hospira Inc. II Aug-31-2011
67 Hospira Inc. II Apr-15-2011
68 Hospira Inc. II Mar-14-2011
69 Hospira Inc. II Mar-08-2011
70 Hospira Inc. II Aug-17-2010
71 Iradimed Corporation II Nov-28-2012
72 MOOG Medical Devices Group II Oct-17-2012
73 MOOG Medical Devices Group II Apr-13-2012
74 Medrad Inc II Dec-20-2012
75 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
76 Roche Insulin Delivery Systems Inc. I Mar-10-2011
77 Sigma III Jul-18-2012
78 Sigma I Jun-13-2012
79 Sigma International General Medical Apparatus, Llc I Nov-05-2010
80 Smiths Medical ASD, Inc. II Mar-26-2013
81 Smiths Medical ASD, Inc. I Aug-01-2012
82 Smiths Medical ASD, Inc. II Mar-14-2012
83 Smiths Medical ASD, Inc. II Aug-02-2010
84 Smiths Medical ASD, Inc. II Apr-05-2010
85 Smiths Medical ASD, Inc. II Jan-15-2010
86 Smiths Medical MD, Inc. II Mar-09-2009
87 Smiths Medical MD, Inc. II Sep-23-2008
88 Smiths Medical MD, Inc. II Aug-24-2008
89 Smiths Medical MD, Inc. II Aug-15-2008
90 Smiths Medical MD, Inc. II Feb-26-2008
91 Smiths Medical MD, Inc. II Feb-13-2008
92 Smiths Medical MD, Inc. II Apr-26-2007
93 Smiths Medical MD, Inc. III Apr-05-2007
94 Stryker Instruments Div. of Stryker Corporation II Oct-20-2010
95 Stryker Instruments Div. of Stryker Corporation II Sep-28-2010
96 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
97 Stryker Instruments Div. of Stryker Corporation II Aug-19-2009
98 Stryker Instruments Div. of Stryker Corporation II Apr-30-2009
99 Stryker Instruments Div. of Stryker Corporation II Feb-02-2009
100 Stryker Instruments Div. of Stryker Corporation II Jan-27-2009
101 Walkmed Infusion LLC I Nov-05-2010
102 Zevex International, Inc. I Apr-05-2011
103 Zevex International, Inc. II Feb-25-2011

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