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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.
  1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 13
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 42
BELMONT INSTRUMENT CORP.
  1
  SUBSTANTIALLY EQUIVALENT 3
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 22
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 8
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 6
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.
  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.
  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 2
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 11
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
  2
  SUBSTANTIALLY EQUIVALENT 4
MEDFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
METTLER ELECTRONICS CORP.
  1
MINNESOTA MINING AND MFG. CO.
  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 2
SABRATEK
  SUBSTANTIALLY EQUIVALENT 4
SIGMA
  SUBSTANTIALLY EQUIVALENT 6
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  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 3

Device Problems
Break 4388
Device displays error message 3627
Device inoperable 3345
Component(s), broken 2454
Failure to sense 2218
Excess flow or overinfusion 1770
Battery failure 1698
Not audible alarm 1452
Infusion or flow issue 1266
Insufficient flow or underinfusion 1067
Failure to deliver 870
Fluid leak 858
Shielding failure 796
Battery issue 703
Defective component 698
Device operates differently than expected 576
Occlusion within device 536
Overheating of device or device component 533
Device alarm system issue 433
Alarm, audible 427
Foreign material present in device 419
Inaccurate flowrate 342
Loss of power 315
Free or unrestricted flow 306
Improper flow or infusion 248
Overdelivery 240
Air leak 221
Bent 210
Inaccurate delivery 199
Use of Device Issue 181
Spark 174
Leak 170
Material separation 165
Sticking 161
No Known Device Problem 158
Burn of device or device component 154
Underdelivery 143
Crack 135
Calibration error 127
Charred 118
Incorrect software programming calculations 108
Disconnection 107
Volume accuracy issue 102
Self-activation or keying 92
Smoking 87
Failure to prime 82
Pumping stopped 79
Imprecision 76
Nonstandard device or device component 75
Loose or intermittent connection 71
Failure to power-up 71
Particulates 68
Calibration issue 64
Pressure sensor failure 63
Device stops intermittently 62
Bubble detector, failure of 61
Application interface becomes non-functional or program exits abnormally 60
Failure to infuse 57
Mechanical issue 56
Electrical issue 56
Incorrect or inadequate result 55
Malfunction 53
Material deformation 53
Pumping issue 53
Reflux within device 52
False alarm 52
Fire 52
No Information 51
Melted 50
Unknown (for use when the device problem is not known) 48
Positioning Issue 48
Fail-safe mechanism issue 45
Communication or transmission issue 45
Moisture damage 44
Material rupture 44
Mechanical jam 42
Low readings 42
No flow 42
Defective Alarm 41
Retraction problem 39
No code available 36
Component missing 35
Filling problem 35
Accuracy rate 32
Other (for use when an appropriate device code cannot be identified) 31
Hole in material 30
Difficult to open or close 30
Incorrect display 28
Erratic display 28
Low battery 28
Material puncture 26
No display or display failure 26
Failure of device to self-test 25
Sensor problems 24
Increased sensitivity 24
Date-related software issue 24
Unintended movement 23
Image display error 22
Protective measure issue 21
Device Issue 21
Total Device Problems 36898

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 3 1 2 7 4 8 8 5 3 0
Class II 6 9 10 9 20 14 17 11 8 4
Class III 1 0 0 0 1 2 0 0 0 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. I Sep-13-2013
6 B Braun Medical, Inc. II Sep-10-2013
7 B Braun Medical, Inc. II Sep-06-2013
8 B Braun Medical, Inc. II Sep-06-2013
9 B. Braun Medical, Inc. II Sep-06-2013
10 B. Braun Medical, Inc. II Dec-31-2012
11 B. Braun Medical, Inc. I Jul-16-2012
12 B. Braun Medical, Inc. I Feb-29-2012
13 B. Braun Medical, Inc. II Sep-23-2008
14 Baxter Healthcare Corp II Apr-16-2015
15 Baxter Healthcare Corp. II Oct-01-2014
16 Baxter Healthcare Corp. I Apr-25-2014
17 Baxter Healthcare Corp. II Nov-08-2013
18 Baxter Healthcare Corp. II Nov-08-2013
19 Baxter Healthcare Corp. II Jun-27-2013
20 Baxter Healthcare Corp. II Jun-27-2013
21 Baxter Healthcare Corp. III Aug-24-2012
22 Baxter Healthcare Corp. II Jan-13-2012
23 Baxter Healthcare Corp. II Jan-11-2012
24 Baxter Healthcare Corp. II Oct-28-2011
25 Baxter Healthcare Corp. II Aug-11-2011
26 Baxter Healthcare Corp. II Aug-11-2011
27 Baxter Healthcare Corp. II Aug-08-2011
28 Baxter Healthcare Corp. II Jul-19-2011
29 Baxter Healthcare Corp. II Jul-13-2011
30 Baxter Healthcare Corp. II May-19-2011
31 Baxter Healthcare Corp. II Apr-29-2011
32 Baxter Healthcare Corp. III Feb-18-2011
33 Baxter Healthcare Corp. II Jan-21-2011
34 Baxter Healthcare Corp. II Jan-21-2011
35 Baxter Healthcare Corp. II Jan-21-2011
36 Baxter Healthcare Corp. I Oct-12-2010
37 Baxter Healthcare Corp. I Mar-02-2009
38 Baxter Healthcare Corp. II Oct-21-2008
39 Baxter Healthcare Corp. I Sep-19-2007
40 Baxter Healthcare Corp. I Jul-28-2007
41 Baxter Healthcare Corp. I Jul-18-2007
42 Baxter Healthcare Corp. II Mar-20-2007
43 Baxter Healthcare Corp. II Jan-11-2007
44 Bayer Corp II May-30-2014
45 Bayer Healthcare II Jan-11-2016
46 Belmont Instrument Corporation II Oct-12-2012
47 CME America, LLC II Feb-19-2015
48 Cardinal Health 303 Inc DBA Alaris Products II Jun-10-2008
49 Cardinal Health 303 Inc DBA Alaris Products I Jan-04-2008
50 Cardinal Health 303 Inc DBA Alaris Products II Aug-03-2007
51 Cardinal Health 303 Inc DBA Alaris Products II Aug-02-2007
52 Cardinal Health 303 dba Cardinal Health I Aug-03-2009
53 Cardinal Health 303 dba Cardinal Health II May-01-2009
54 Cardinal Health 303 dba Cardinal Health II Apr-07-2009
55 CareFusion 303, Inc. II May-04-2016
56 CareFusion 303, Inc. I Aug-14-2015
57 CareFusion 303, Inc. II Jun-16-2015
58 CareFusion 303, Inc. II Mar-23-2015
59 CareFusion 303, Inc. I May-14-2014
60 CareFusion 303, Inc. I Dec-20-2013
61 CareFusion 303, Inc. I Aug-02-2013
62 CareFusion 303, Inc. I Aug-17-2012
63 CareFusion 303, Inc. I Aug-15-2012
64 CareFusion 303, Inc. I Jul-26-2012
65 CareFusion 303, Inc. II Jan-26-2012
66 CareFusion Corporation II Jun-26-2015
67 CareFusion Corporation I Oct-13-2010
68 Carefusion Corporation I Apr-15-2013
69 Carefusion Corporation II Apr-15-2013
70 Curlin Medical Llc II Sep-22-2008
71 Elite Biomedical Solutions LLC I Aug-20-2015
72 Hospira Inc II Mar-08-2011
73 Hospira Inc I Oct-22-2010
74 Hospira Inc II Sep-09-2010
75 Hospira Inc I Sep-08-2010
76 Hospira Inc I Jul-02-2010
77 Hospira Inc II Oct-06-2009
78 Hospira Inc II Aug-11-2009
79 Hospira Inc II Feb-27-2009
80 Hospira Inc. II Feb-23-2016
81 Hospira Inc. I Feb-23-2015
82 Hospira Inc. II Feb-04-2015
83 Hospira Inc. II Nov-24-2014
84 Hospira Inc. I Oct-24-2014
85 Hospira Inc. II Jul-10-2014
86 Hospira Inc. II Jul-10-2014
87 Hospira Inc. II Jun-03-2014
88 Hospira Inc. I May-01-2014
89 Hospira Inc. I May-01-2014
90 Hospira Inc. II Apr-21-2014
91 Hospira Inc. I Nov-21-2013
92 Hospira Inc. II Nov-20-2013
93 Hospira Inc. II Nov-14-2013
94 Hospira Inc. II Nov-14-2013
95 Hospira Inc. II Aug-01-2013
96 Hospira Inc. I Apr-30-2013
97 Hospira Inc. I Apr-26-2013
98 Hospira Inc. II Apr-15-2013
99 Hospira Inc. II Dec-31-2012
100 Hospira Inc. II Dec-07-2012
101 Hospira Inc. I Oct-19-2012
102 Hospira Inc. II May-04-2012
103 Hospira Inc. II Apr-26-2012
104 Hospira Inc. II Oct-04-2011
105 Hospira Inc. II Sep-29-2011
106 Hospira Inc. II Aug-31-2011
107 Hospira Inc. II Apr-15-2011
108 Hospira Inc. II Mar-14-2011
109 Hospira Inc. II Mar-08-2011
110 Hospira Inc. II Aug-17-2010
111 Intra Pump Infusion Systems II Oct-21-2014
112 Iradimed Corporation I Aug-02-2013
113 Iradimed Corporation II Nov-28-2012
114 MOOG Medical Devices Group II Feb-11-2016
115 MOOG Medical Devices Group II Oct-17-2012
116 MOOG Medical Devices Group II Apr-13-2012
117 Medrad Inc II Dec-20-2012
118 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
119 Medtronic MiniMed II Aug-20-2013
120 Medtronic MiniMed Inc. II Jul-24-2015
121 Medtronic MiniMed Inc. II Aug-08-2014
122 Roche Insulin Delivery Systems Inc. I Mar-10-2011
123 Sigma III Jul-18-2012
124 Sigma I Jun-13-2012
125 Sigma International General Medical Apparatus, Llc I Nov-05-2010
126 Smiths Medical ASD, Inc. II Dec-19-2013
127 Smiths Medical ASD, Inc. II Mar-26-2013
128 Smiths Medical ASD, Inc. I Aug-01-2012
129 Smiths Medical ASD, Inc. II Mar-14-2012
130 Smiths Medical ASD, Inc. II Aug-02-2010
131 Smiths Medical ASD, Inc. II Apr-05-2010
132 Smiths Medical ASD, Inc. II Jan-15-2010
133 Smiths Medical MD, Inc. II Mar-09-2009
134 Smiths Medical MD, Inc. II Sep-23-2008
135 Smiths Medical MD, Inc. II Aug-24-2008
136 Smiths Medical MD, Inc. II Aug-15-2008
137 Smiths Medical MD, Inc. II Feb-26-2008
138 Smiths Medical MD, Inc. II Feb-13-2008
139 Smiths Medical MD, Inc. II Apr-26-2007
140 Smiths Medical MD, Inc. III Apr-05-2007
141 Stryker Instruments Div. of Stryker Corporation II Oct-20-2010
142 Stryker Instruments Div. of Stryker Corporation II Sep-28-2010
143 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
144 Stryker Instruments Div. of Stryker Corporation II Aug-19-2009
145 Stryker Instruments Div. of Stryker Corporation II Apr-30-2009
146 Stryker Instruments Div. of Stryker Corporation II Feb-02-2009
147 Stryker Instruments Div. of Stryker Corporation II Jan-27-2009
148 The Anspach Effort, Inc. II May-16-2014
149 WalkMed Infusion, LLC II Nov-06-2015
150 WalkMed Infusion, LLC II Mar-03-2014
151 Walkmed Infusion LLC I Nov-05-2010
152 Zevex International, Inc. I Apr-05-2011
153 Zevex International, Inc. II Feb-25-2011

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