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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
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BELMONT INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARTICEPT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
CARTICEPT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
HK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 3
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 2
Q CORE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS GROUP PLC
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
ZYNO MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 7733
Break 4344
Device inoperable 2726
Excess flow or overinfusion 2535
Failure to sense 1884
Device operates differently than expected 1873
Infusion or flow issue 1602
Insufficient flow or underinfusion 1449
Not audible alarm 820
Battery issue 811
Fluid leak 803
Shielding failure 796
Device alarm system issue 773
False alarm 587
Overheating of device or device component 543
Foreign material present in device 438
Improper flow or infusion 397
Failure to deliver 384
Occlusion within device 377
Free or unrestricted flow 365
No Known Device Problem 280
Pumping stopped 265
Leak 263
Inaccurate flowrate 214
Loss of power 212
Inaccurate delivery 188
Material rupture 181
Disconnection 173
Crack 171
Air leak 170
Burn of device or device component 167
No display or display failure 160
Sticking 148
Volume accuracy issue 146
Failure to power-up 141
Filling problem 136
Mechanical issue 120
Alarm, audible 117
Communication or transmission issue 111
Use of Device Issue 104
No code available 101
Spark 96
Material separation 91
Bent 90
Smoking 90
No Information 88
Failure to infuse 84
No flow 81
Inadequate user interface 80
Loose or intermittent connection 76
Nonstandard device or device component 75
Failure to prime 73
Protective measure issue 70
Electrical issue 60
Particulates 59
Component missing 58
Device Issue 58
Incorrect or inadequate result 57
Pumping issue 55
Power source issue 54
Device stops intermittently 51
Moisture damage 50
Positioning Issue 49
Fire 48
Calibration error 47
Programming issue 46
Fail-safe mechanism issue 46
Improper alarm 45
Mechanical jam 43
Image display error 42
Low readings 42
Low battery 41
Retraction problem 40
Charred 39
Incorrect display 38
Pressure issue 38
Charging issue 38
Device sensing issue 37
Connection issue 37
Self-activation or keying 36
Increase in pressure 35
Improper or incorrect procedure or method 35
Material integrity issue 33
Defective Alarm 33
Difficult to open or close 32
Calibration issue 30
Device or device component damaged by another device 29
Defective component 29
Melted 28
Hole in material 28
Material deformation 27
Failure of device to self-test 26
Material puncture 26
Corrosion 24
Increased sensitivity 24
Date-related software issue 23
Erratic display 23
Kinked 22
Temperature issue 21
Cut in material 20
Total Device Problems 37604

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-25-2015
2 B Braun Medical, Inc. I Sep-13-2013
3 B Braun Medical, Inc. II Sep-10-2013
4 B Braun Medical, Inc. II Sep-06-2013
5 B Braun Medical, Inc. II Sep-06-2013
6 B. Braun Medical, Inc. II Sep-06-2013
7 Baxter Healthcare Corp II Apr-16-2015
8 Baxter Healthcare Corp. II Nov-29-2016
9 Baxter Healthcare Corp. II Oct-01-2014
10 Baxter Healthcare Corp. I Apr-25-2014
11 Baxter Healthcare Corp. II Nov-08-2013
12 Baxter Healthcare Corp. II Nov-08-2013
13 Baxter Healthcare Corp. II Jun-27-2013
14 Baxter Healthcare Corp. II Jun-27-2013
15 Baxter Healthcare Corporation II Jun-07-2018
16 Baxter Healthcare Corporation II May-04-2018
17 Baxter Healthcare Corporation II Mar-12-2018
18 Baxter Healthcare Corporation II Oct-02-2017
19 Bayer Corp II May-30-2014
20 Bayer Healthcare II Feb-08-2017
21 Bayer Healthcare II Nov-11-2016
22 Bayer Healthcare II Jan-11-2016
23 CME America, LLC II Feb-19-2015
24 CareFusion 303, Inc. II Jan-08-2018
25 CareFusion 303, Inc. II Oct-19-2017
26 CareFusion 303, Inc. II Jun-19-2017
27 CareFusion 303, Inc. II Jun-19-2017
28 CareFusion 303, Inc. II Mar-21-2017
29 CareFusion 303, Inc. I Jan-18-2017
30 CareFusion 303, Inc. II Sep-23-2016
31 CareFusion 303, Inc. II Jun-28-2016
32 CareFusion 303, Inc. II May-04-2016
33 CareFusion 303, Inc. I Aug-14-2015
34 CareFusion 303, Inc. II Jun-16-2015
35 CareFusion 303, Inc. II Mar-23-2015
36 CareFusion 303, Inc. I May-14-2014
37 CareFusion 303, Inc. I Dec-20-2013
38 CareFusion 303, Inc. I Aug-02-2013
39 CareFusion Corporation II Jun-26-2015
40 Carefusion Corporation I Apr-15-2013
41 Carefusion Corporation II Apr-15-2013
42 Elite Biomedical Solutions LLC I Aug-20-2015
43 Hospira Inc. II Nov-04-2016
44 Hospira Inc. II Nov-03-2016
45 Hospira Inc. II Oct-24-2016
46 Hospira Inc. II Sep-06-2016
47 Hospira Inc. II Jul-08-2016
48 Hospira Inc. II Jun-27-2016
49 Hospira Inc. II Jun-03-2016
50 Hospira Inc. II Feb-23-2016
51 Hospira Inc. I Feb-23-2015
52 Hospira Inc. II Feb-04-2015
53 Hospira Inc. II Nov-24-2014
54 Hospira Inc. I Oct-24-2014
55 Hospira Inc. II Jul-10-2014
56 Hospira Inc. II Jul-10-2014
57 Hospira Inc. II Jun-03-2014
58 Hospira Inc. I May-01-2014
59 Hospira Inc. I May-01-2014
60 Hospira Inc. II Apr-21-2014
61 Hospira Inc. I Nov-21-2013
62 Hospira Inc. II Nov-20-2013
63 Hospira Inc. II Nov-14-2013
64 Hospira Inc. II Nov-14-2013
65 Hospira Inc. II Aug-01-2013
66 Hospira Inc. I Apr-30-2013
67 Hospira Inc. I Apr-26-2013
68 Hospira Inc. II Apr-15-2013
69 Hospira Inc., A Pfizer Company II Mar-24-2017
70 Hospira Inc., A Pfizer Company II Sep-13-2016
71 ICU II Jul-07-2017
72 ICU Medical Inc II Dec-06-2017
73 ICU Medical Inc II Nov-16-2017
74 ICU Medical Inc II Aug-14-2017
75 Intra Pump Infusion Systems II Oct-21-2014
76 Iradimed Corporation I Aug-02-2013
77 MOOG Medical Devices Group II Feb-11-2016
78 Medtronic MiniMed II Aug-20-2013
79 Medtronic MiniMed Inc. II Jul-24-2015
80 Medtronic MiniMed Inc. II Aug-08-2014
81 Repro-Med Systems, Inc. II Jan-05-2018
82 Smiths Medical ASD Inc. II Mar-05-2018
83 Smiths Medical ASD Inc. II Jan-04-2018
84 Smiths Medical ASD Inc. II Jan-02-2018
85 Smiths Medical ASD Inc. II Nov-01-2017
86 Smiths Medical ASD Inc. II Aug-25-2017
87 Smiths Medical ASD, Inc. II Dec-19-2013
88 Smiths Medical ASD, Inc. II Mar-26-2013
89 The Anspach Effort, Inc. II May-16-2014
90 WalkMed Infusion, LLC II Jul-18-2016
91 WalkMed Infusion, LLC II Nov-06-2015
92 WalkMed Infusion, LLC II Mar-03-2014
93 WalkMed, LLC II Nov-13-2017

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