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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
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
ZYNO MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 8035
Break 4356
Excess Flow or Over-Infusion 2896
Device Inoperable 2726
Device Operates Differently Than Expected 1976
Failure to Sense 1936
Infusion or Flow Problem 1720
Insufficient Flow or Under Infusion 1646
Device Alarm System 1493
False Alarm 1014
Fluid Leak 944
No Audible Alarm 841
Battery Problem 822
Shielding Failure 796
Overheating of Device 547
Improper Flow or Infusion 525
Adverse Event Without Identified Device or Use Problem 451
Device Contamination with Chemical or Other Material 444
Failure to Deliver 393
Occlusion Within Device 383
Free or Unrestricted Flow 373
Pumping Stopped 287
Leak / Splash 271
Output Problem 263
Inaccurate Flow rate 255
Material Rupture 232
Inaccurate Delivery 225
Loss of Power 213
No Display / Image 204
Disconnection 181
Crack 180
Appropriate Term/Code Not Available 180
Thermal Decomposition of Device 174
Air Leak 170
Mechanical Problem 163
Volume Accuracy Problem 158
Obstruction of Flow 156
Filling Problem 149
Sticking 148
Failure to Power Up 147
Communication or Transmission Problem 120
Alarm, audible 117
Use of Device Problem 108
Protective Measures Problem 104
Sparking 98
Insufficient Information 96
No Flow 94
Smoking 94
Material Separation 92
Bent 90
Difficult or Delayed Activation 89
Failure to Infuse 87
Device Operational Issue 87
Electrical /Electronic Property Problem 84
Inadequate User Interface 83
Defective Alarm 82
No Apparent Adverse Event 80
Loose or Intermittent Connection 76
Nonstandard device 75
Failure to Prime 73
Device Issue 65
Power Problem 60
Component Missing 59
Particulates 59
Incorrect, Inadequate or Imprecise Result 58
Pumping Problem 57
Moisture Damage 53
Device Stops Intermittently 51
Material Integrity Problem 51
Fail-Safe Problem 50
Fire 50
Device Sensing Problem 49
Positioning Problem 49
Programming Issue 49
Improper Alarm 47
Calibration Error 47
Mechanical Jam 43
Low Readings 42
Self-Activation or Keying 42
Retraction Problem 42
Image Display Error / Artifact 42
Low Battery 41
Connection Problem 40
Improper or Incorrect Procedure or Method 40
Display or Visual Feedback Problem 40
Charred 39
Increase in Pressure 39
Pressure Problem 39
Charging Problem 38
Calibration Problem 35
No Audible Prompt / Feedback 35
Difficult to Open or Close 33
Defective Component 31
Device Damaged by Another Device 30
Melted 28
Hole In Material 28
Material Deformation 27
Failure of Device to Self-Test 26
Corroded 26
Failure to Charge 26
Total Device Problems 41608

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 Aug-08-2018
83 Smiths Medical ASD Inc. II Mar-05-2018
84 Smiths Medical ASD Inc. II Jan-04-2018
85 Smiths Medical ASD Inc. II Jan-02-2018
86 Smiths Medical ASD Inc. II Nov-01-2017
87 Smiths Medical ASD Inc. II Aug-25-2017
88 Smiths Medical ASD, Inc. II Dec-19-2013
89 Smiths Medical ASD, Inc. II Mar-26-2013
90 The Anspach Effort, Inc. II May-16-2014
91 WalkMed Infusion, LLC II Jul-18-2016
92 WalkMed Infusion, LLC II Nov-06-2015
93 WalkMed Infusion, LLC II Mar-03-2014
94 WalkMed, LLC II Nov-13-2017

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