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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 12
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 3
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 4

Device Problems
Device displays error message 7166
Break 4462
Device inoperable 3356
Excess flow or overinfusion 2649
Component(s), broken 2454
Failure to sense 2220
Battery failure 1698
Infusion or flow issue 1591
Not audible alarm 1498
Insufficient flow or underinfusion 1475
Device operates differently than expected 1245
Fluid leak 992
Failure to deliver 872
Shielding failure 796
Battery issue 775
Defective component 700
Device alarm system issue 648
Occlusion within device 550
Overheating of device or device component 536
Foreign material present in device 434
Alarm, audible 427
Improper flow or infusion 408
Inaccurate flowrate 395
Free or unrestricted flow 386
Loss of power 329
Leak 263
No Known Device Problem 256
Pumping stopped 251
Inaccurate delivery 243
Overdelivery 240
Use of Device Issue 227
Air leak 224
Bent 205
Spark 196
Burn of device or device component 186
Disconnection 174
Failure to power-up 169
Material separation 165
Sticking 162
Crack 157
Material rupture 155
False alarm 147
Underdelivery 143
Calibration error 130
Charred 122
Filling problem 119
Smoking 116
Volume accuracy issue 114
Incorrect software programming calculations 108
Failure to infuse 94
Self-activation or keying 92
No display or display failure 89
Mechanical issue 88
Communication or transmission issue 87
Failure to prime 84
No flow 76
Nonstandard device or device component 75
Loose or intermittent connection 75
No code available 74
No Information 73
Electrical issue 71
Particulates 68
Fire 66
Pumping issue 65
Pressure sensor failure 63
Calibration issue 63
Bubble detector, failure of 61
Inadequate user interface 60
Reflux within device 59
Melted 58
Incorrect or inadequate result 55
Component missing 53
Malfunction 53
Protective measure issue 52
Positioning Issue 49
Moisture damage 49
Unknown (for use when the device problem is not known) 48
Defective Alarm 47
Device stops intermittently 45
Fail-safe mechanism issue 44
Mechanical jam 43
Low readings 42
Device Issue 42
Power source issue 41
Retraction problem 40
Incorrect display 38
Connection issue 36
Low battery 34
Difficult to open or close 32
Improper or incorrect procedure or method 32
Accuracy rate 32
Hole in material 31
Other (for use when an appropriate device code cannot be identified) 31
Device sensing issue 29
Failure of device to self-test 26
Material puncture 26
Material deformation 25
Programming issue 25
Increased sensitivity 24
Date-related software issue 24
Total Device Problems 45023

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 3 1 2 7 4 8 8 5 3 0 1
Class II 6 9 10 9 20 14 17 11 8 17 13
Class III 1 0 0 0 1 2 0 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 Nov-29-2016
16 Baxter Healthcare Corp. II Oct-01-2014
17 Baxter Healthcare Corp. I Apr-25-2014
18 Baxter Healthcare Corp. II Nov-08-2013
19 Baxter Healthcare Corp. II Nov-08-2013
20 Baxter Healthcare Corp. II Jun-27-2013
21 Baxter Healthcare Corp. II Jun-27-2013
22 Baxter Healthcare Corp. III Aug-24-2012
23 Baxter Healthcare Corp. II Jan-13-2012
24 Baxter Healthcare Corp. II Jan-11-2012
25 Baxter Healthcare Corp. II Oct-28-2011
26 Baxter Healthcare Corp. II Aug-11-2011
27 Baxter Healthcare Corp. II Aug-11-2011
28 Baxter Healthcare Corp. II Aug-08-2011
29 Baxter Healthcare Corp. II Jul-19-2011
30 Baxter Healthcare Corp. II Jul-13-2011
31 Baxter Healthcare Corp. II May-19-2011
32 Baxter Healthcare Corp. II Apr-29-2011
33 Baxter Healthcare Corp. III Feb-18-2011
34 Baxter Healthcare Corp. II Jan-21-2011
35 Baxter Healthcare Corp. II Jan-21-2011
36 Baxter Healthcare Corp. II Jan-21-2011
37 Baxter Healthcare Corp. I Oct-12-2010
38 Baxter Healthcare Corp. I Mar-02-2009
39 Baxter Healthcare Corp. II Oct-21-2008
40 Baxter Healthcare Corp. I Sep-19-2007
41 Baxter Healthcare Corp. I Jul-28-2007
42 Baxter Healthcare Corp. I Jul-18-2007
43 Baxter Healthcare Corp. II Mar-20-2007
44 Baxter Healthcare Corp. II Jan-11-2007
45 Baxter Healthcare Corporation II Oct-02-2017
46 Baxter Healthcare Corporation I Jun-13-2012
47 Bayer Corp II May-30-2014
48 Bayer Healthcare II Feb-08-2017
49 Bayer Healthcare II Nov-11-2016
50 Bayer Healthcare II Jan-11-2016
51 Belmont Instrument Corporation II Oct-12-2012
52 CME America, LLC II Feb-19-2015
53 Cardinal Health 303 Inc DBA Alaris Products II Jun-10-2008
54 Cardinal Health 303 Inc DBA Alaris Products I Jan-04-2008
55 Cardinal Health 303 Inc DBA Alaris Products II Aug-03-2007
56 Cardinal Health 303 Inc DBA Alaris Products II Aug-02-2007
57 Cardinal Health 303 dba Cardinal Health I Aug-03-2009
58 Cardinal Health 303 dba Cardinal Health II May-01-2009
59 Cardinal Health 303 dba Cardinal Health II Apr-07-2009
60 CareFusion 303, Inc. II Oct-19-2017
61 CareFusion 303, Inc. II Jun-19-2017
62 CareFusion 303, Inc. II Jun-19-2017
63 CareFusion 303, Inc. II Mar-21-2017
64 CareFusion 303, Inc. I Jan-18-2017
65 CareFusion 303, Inc. II Sep-23-2016
66 CareFusion 303, Inc. II Jun-28-2016
67 CareFusion 303, Inc. II May-04-2016
68 CareFusion 303, Inc. I Aug-14-2015
69 CareFusion 303, Inc. II Jun-16-2015
70 CareFusion 303, Inc. II Mar-23-2015
71 CareFusion 303, Inc. I May-14-2014
72 CareFusion 303, Inc. I Dec-20-2013
73 CareFusion 303, Inc. I Aug-02-2013
74 CareFusion 303, Inc. I Aug-17-2012
75 CareFusion 303, Inc. I Aug-15-2012
76 CareFusion 303, Inc. I Jul-26-2012
77 CareFusion 303, Inc. II Jan-26-2012
78 CareFusion Corporation II Jun-26-2015
79 CareFusion Corporation I Oct-13-2010
80 Carefusion Corporation I Apr-15-2013
81 Carefusion Corporation II Apr-15-2013
82 Curlin Medical Llc II Sep-22-2008
83 Elite Biomedical Solutions LLC I Aug-20-2015
84 Hospira Inc II Mar-08-2011
85 Hospira Inc I Oct-22-2010
86 Hospira Inc II Sep-09-2010
87 Hospira Inc I Sep-08-2010
88 Hospira Inc I Jul-02-2010
89 Hospira Inc II Oct-06-2009
90 Hospira Inc II Aug-11-2009
91 Hospira Inc II Feb-27-2009
92 Hospira Inc. II Nov-04-2016
93 Hospira Inc. II Nov-03-2016
94 Hospira Inc. II Oct-24-2016
95 Hospira Inc. II Sep-06-2016
96 Hospira Inc. II Jul-08-2016
97 Hospira Inc. II Jun-27-2016
98 Hospira Inc. II Jun-03-2016
99 Hospira Inc. II Feb-23-2016
100 Hospira Inc. I Feb-23-2015
101 Hospira Inc. II Feb-04-2015
102 Hospira Inc. II Nov-24-2014
103 Hospira Inc. I Oct-24-2014
104 Hospira Inc. II Jul-10-2014
105 Hospira Inc. II Jul-10-2014
106 Hospira Inc. II Jun-03-2014
107 Hospira Inc. I May-01-2014
108 Hospira Inc. I May-01-2014
109 Hospira Inc. II Apr-21-2014
110 Hospira Inc. I Nov-21-2013
111 Hospira Inc. II Nov-20-2013
112 Hospira Inc. II Nov-14-2013
113 Hospira Inc. II Nov-14-2013
114 Hospira Inc. II Aug-01-2013
115 Hospira Inc. I Apr-30-2013
116 Hospira Inc. I Apr-26-2013
117 Hospira Inc. II Apr-15-2013
118 Hospira Inc. II Dec-31-2012
119 Hospira Inc. II Dec-07-2012
120 Hospira Inc. I Oct-19-2012
121 Hospira Inc. II May-04-2012
122 Hospira Inc. II Apr-26-2012
123 Hospira Inc. II Oct-04-2011
124 Hospira Inc. II Sep-29-2011
125 Hospira Inc. II Aug-31-2011
126 Hospira Inc. II Apr-15-2011
127 Hospira Inc. II Mar-14-2011
128 Hospira Inc. II Mar-08-2011
129 Hospira Inc. II Aug-17-2010
130 Hospira Inc., A Pfizer Company II Mar-24-2017
131 Hospira Inc., A Pfizer Company II Sep-13-2016
132 ICU II Jul-07-2017
133 ICU Medical Inc II Nov-16-2017
134 ICU Medical Inc II Aug-14-2017
135 Intra Pump Infusion Systems II Oct-21-2014
136 Iradimed Corporation I Aug-02-2013
137 Iradimed Corporation II Nov-28-2012
138 MOOG Medical Devices Group II Feb-11-2016
139 MOOG Medical Devices Group II Oct-17-2012
140 MOOG Medical Devices Group II Apr-13-2012
141 Medrad Inc II Dec-20-2012
142 Medtronic Emergency Response Systems, Inc. II Jun-21-2007
143 Medtronic MiniMed II Aug-20-2013
144 Medtronic MiniMed Inc. II Jul-24-2015
145 Medtronic MiniMed Inc. II Aug-08-2014
146 Roche Insulin Delivery Systems Inc. I Mar-10-2011
147 Sigma III Jul-18-2012
148 Sigma International General Medical Apparatus, Llc I Nov-05-2010
149 Smiths Medical ASD Inc. II Nov-01-2017
150 Smiths Medical ASD Inc. II Aug-25-2017
151 Smiths Medical ASD, Inc. II Dec-19-2013
152 Smiths Medical ASD, Inc. II Mar-26-2013
153 Smiths Medical ASD, Inc. I Aug-01-2012
154 Smiths Medical ASD, Inc. II Mar-14-2012
155 Smiths Medical ASD, Inc. II Aug-02-2010
156 Smiths Medical ASD, Inc. II Apr-05-2010
157 Smiths Medical ASD, Inc. II Jan-15-2010
158 Smiths Medical MD, Inc. II Mar-09-2009
159 Smiths Medical MD, Inc. II Sep-23-2008
160 Smiths Medical MD, Inc. II Aug-24-2008
161 Smiths Medical MD, Inc. II Aug-15-2008
162 Smiths Medical MD, Inc. II Feb-26-2008
163 Smiths Medical MD, Inc. II Feb-13-2008
164 Smiths Medical MD, Inc. II Apr-26-2007
165 Smiths Medical MD, Inc. III Apr-05-2007
166 Stryker Instruments Div. of Stryker Corporation II Oct-20-2010
167 Stryker Instruments Div. of Stryker Corporation II Sep-28-2010
168 Stryker Instruments Div. of Stryker Corporation II Sep-03-2010
169 Stryker Instruments Div. of Stryker Corporation II Aug-19-2009
170 Stryker Instruments Div. of Stryker Corporation II Apr-30-2009
171 Stryker Instruments Div. of Stryker Corporation II Feb-02-2009
172 Stryker Instruments Div. of Stryker Corporation II Jan-27-2009
173 The Anspach Effort, Inc. II May-16-2014
174 WalkMed Infusion, LLC II Jul-18-2016
175 WalkMed Infusion, LLC II Nov-06-2015
176 WalkMed Infusion, LLC II Mar-03-2014
177 WalkMed, LLC II Nov-13-2017
178 Walkmed Infusion LLC I Nov-05-2010
179 Zevex International, Inc. I Apr-05-2011
180 Zevex International, Inc. II Feb-25-2011

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