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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 5637
Break 4451
Device inoperable 3347
Component(s), broken 2454
Excess flow or overinfusion 2406
Failure to sense 2219
Battery failure 1698
Infusion or flow issue 1537
Not audible alarm 1480
Insufficient flow or underinfusion 1356
Fluid leak 982
Device operates differently than expected 911
Failure to deliver 871
Shielding failure 796
Battery issue 724
Defective component 700
Device alarm system issue 591
Occlusion within device 544
Overheating of device or device component 533
Foreign material present in device 434
Alarm, audible 427
Inaccurate flowrate 375
Free or unrestricted flow 365
Improper flow or infusion 326
Loss of power 324
Leak 243
Overdelivery 240
Inaccurate delivery 233
Air leak 223
No Known Device Problem 215
Use of Device Issue 206
Bent 205
Pumping stopped 201
Spark 193
Burn of device or device component 174
Material separation 165
Sticking 162
Disconnection 162
Failure to power-up 154
Crack 153
Underdelivery 143
Material rupture 141
False alarm 131
Calibration error 128
Charred 118
Volume accuracy issue 110
Incorrect software programming calculations 108
Filling problem 105
Smoking 102
Self-activation or keying 92
Failure to infuse 89
Failure to prime 84
Communication or transmission issue 82
Nonstandard device or device component 75
Loose or intermittent connection 73
No flow 70
Particulates 68
No Information 68
Mechanical issue 67
Electrical issue 67
Fire 65
Pumping issue 65
Calibration issue 63
Pressure sensor failure 63
Bubble detector, failure of 61
No code available 59
Reflux within device 57
Melted 56
Incorrect or inadequate result 55
Malfunction 53
Component missing 50
Positioning Issue 49
Unknown (for use when the device problem is not known) 48
Moisture damage 48
No display or display failure 48
Defective Alarm 47
Fail-safe mechanism issue 44
Device stops intermittently 43
Low readings 42
Mechanical jam 42
Device Issue 41
Retraction problem 39
Power source issue 38
Protective measure issue 38
Connection issue 36
Low battery 34
Incorrect display 34
Accuracy rate 32
Difficult to open or close 32
Other (for use when an appropriate device code cannot be identified) 31
Hole in material 30
Improper or incorrect procedure or method 27
Failure of device to self-test 26
Material puncture 26
Sensor problems 24
Erratic display 24
Date-related software issue 24
Increased sensitivity 24
Image display error 22
Kinked 22
Total Device Problems 42000

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

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