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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 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARTICEPT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Displays Incorrect Message 8176
Device Alarm System 7440
Excess Flow or Over-Infusion 5156
Insufficient Flow or Under Infusion 3865
False Alarm 3594
Pump 2819
Keypad 2020
Improper Flow or Infusion 2002
Device Operates Differently Than Expected 1910
Infusion or Flow Problem 1788
Fluid Leak 1687
Defective Alarm 1065
No Apparent Adverse Event 1062
Break 972
Failure to Sense 971
Adverse Event Without Identified Device or Use Problem 961
Obstruction of Flow 846
Output Problem 818
Pumping Stopped 674
Battery Problem 599
Reservoir 548
Device Contamination with Chemical or Other Material 542
Inaccurate Delivery 531
Alarm 502
Inaccurate Flow rate 490
Free or Unrestricted Flow 448
Appropriate Term/Code Not Available 447
Mechanical Problem 431
No Display / Image 409
Protective Measures Problem 407
Difficult or Delayed Activation 387
Material Rupture 369
Volume Accuracy Problem 342
Complete Loss of power 322
Leak / Splash 318
Alarm, Audible 312
Alarm, Visual 294
Communication or Transmission Problem 291
Patient Device Interaction Problem 286
No Audible Alarm 281
Electrical /Electronic Property Problem 253
Battery 250
Failure to Deliver 240
Computer Software Problem 230
No Audible Prompt / Feedback 227
Tube 216
Insufficient Information 214
Unexpected Shutdown 212
Disconnection 212
Device Inoperable 208
Screen 192
Crack 188
Improper or Incorrect Procedure or Method 183
Use of Device Problem 173
Cassette 170
Filling Problem 168
Post 163
Failure to Infuse 159
Power Problem 159
Occlusion Within Device 153
Device Sensing Problem 152
Thermal Decomposition of Device 146
Connection Problem 144
Device Component Or Accessory 144
Failure to Power Up 144
Power Cord 143
Motor 140
Device Difficult to Setup or Prepare 137
No Flow 136
Material Integrity Problem 134
Housing 131
Pressure Problem 130
Intermittent loss of power 118
Guide 111
Air Leak 108
Failure to Align 108
Display or Visual Feedback Problem 106
Sensor 105
Overheating of Device 100
Inadequate User Interface 91
Adapter (Adaptor) 90
Smoking 89
Latch 89
Corroded 88
Device Operational Issue 87
Scratched Material 83
Application Program Problem 81
Calibration Problem 80
Nonstandard device 75
Operating System Version or Upgrade Problem 75
Cap 74
Component Missing 70
Incorrect, Inadequate or Imprecise Result or Readings 68
Increase in Pressure 67
Sensing Intermittently 67
Loss of Power 66
Device Issue 64
Clamp 63
Fail-Safe Problem 62
Pumping Problem 61
Total Device Problems 64379

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-25-2015
2 Baxter Healthcare Corp II Apr-16-2015
3 Baxter Healthcare Corp. II Nov-29-2016
4 Baxter Healthcare Corporation II May-02-2019
5 Baxter Healthcare Corporation II Jun-07-2018
6 Baxter Healthcare Corporation II May-04-2018
7 Baxter Healthcare Corporation II Mar-12-2018
8 Baxter Healthcare Corporation II Oct-02-2017
9 Bayer Healthcare II Feb-08-2017
10 Bayer Healthcare II Nov-11-2016
11 Bayer Healthcare II Jan-11-2016
12 CME America, LLC I Mar-18-2020
13 CME America, LLC I Mar-11-2020
14 CME America, LLC II Feb-19-2015
15 CareFusion 303, Inc. I Mar-05-2020
16 CareFusion 303, Inc. I Jul-16-2019
17 CareFusion 303, Inc. II Jan-08-2018
18 CareFusion 303, Inc. II Oct-19-2017
19 CareFusion 303, Inc. II Jun-19-2017
20 CareFusion 303, Inc. II Jun-19-2017
21 CareFusion 303, Inc. II Mar-21-2017
22 CareFusion 303, Inc. I Jan-18-2017
23 CareFusion 303, Inc. II Sep-23-2016
24 CareFusion 303, Inc. II Jun-28-2016
25 CareFusion 303, Inc. II May-04-2016
26 CareFusion 303, Inc. I Aug-14-2015
27 CareFusion 303, Inc. II Jun-16-2015
28 CareFusion 303, Inc. II Mar-23-2015
29 CareFusion Corporation II Jun-26-2015
30 Elite Biomedical Solutions LLC I Aug-20-2015
31 Fenwal Inc I Aug-12-2019
32 Fresenius Vial Sa II Nov-02-2018
33 Hospira Inc. II Nov-04-2016
34 Hospira Inc. II Nov-03-2016
35 Hospira Inc. II Oct-24-2016
36 Hospira Inc. II Sep-06-2016
37 Hospira Inc. II Jul-08-2016
38 Hospira Inc. II Jun-27-2016
39 Hospira Inc. II Jun-03-2016
40 Hospira Inc. II Feb-23-2016
41 Hospira Inc. I Feb-23-2015
42 Hospira Inc. II Feb-04-2015
43 Hospira Inc., A Pfizer Company II Mar-24-2017
44 Hospira Inc., A Pfizer Company II Sep-13-2016
45 ICU II Jul-07-2017
46 ICU Medical Inc II Oct-22-2019
47 ICU Medical Inc II Oct-14-2019
48 ICU Medical Inc II Dec-06-2017
49 ICU Medical Inc II Nov-16-2017
50 ICU Medical Inc II Aug-14-2017
51 InfuTronix LLC II Jul-23-2019
52 MOOG Medical Devices Group II Feb-11-2016
53 Medtronic MiniMed Inc. II Jul-24-2015
54 Repro-Med Systems, Inc. II Jan-05-2018
55 Smiths Medical ASD Inc. I Dec-12-2019
56 Smiths Medical ASD Inc. II Aug-08-2018
57 Smiths Medical ASD Inc. II Mar-05-2018
58 Smiths Medical ASD Inc. II Jan-04-2018
59 Smiths Medical ASD Inc. II Jan-02-2018
60 Smiths Medical ASD Inc. II Nov-01-2017
61 Smiths Medical ASD Inc. II Aug-25-2017
62 WalkMed Infusion, LLC II Jul-18-2016
63 WalkMed Infusion, LLC II Nov-06-2015
64 WalkMed, LLC II Nov-13-2017
65 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019

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