Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pump, infusion
Regulation Description Infusion pump.
Product CodeFRN
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
BELMONT MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
EITAN MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KORU MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
KORU MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
REPRO-MEDICAL SYSTEM, INC., DBA KORU MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ZEVEX, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 199342 199405
2022 888020 888163
2023 165838 165883
2024 57730 57739
2025 53488 53488
2026 17549 17550

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 712314 712316
Corroded 199719 199720
Break 121839 121843
Display Difficult to Read 89745 89745
Device Sensing Problem 56504 56504
Failure to Read Input Signal 50689 50689
Contamination 32534 32535
Device Alarm System 30858 30882
No Apparent Adverse Event 21156 21157
Physical Resistance/Sticking 18188 18188
Failure to Calibrate 14571 14571
Battery Problem 14524 14527
Failure to Sense 11788 11789
Circuit Failure 11337 11337
No Display/Image 11155 11156
Premature Discharge of Battery 10482 10483
Failure to Align 10390 10390
Insufficient Information 9964 9964
Display or Visual Feedback Problem 9625 9628
Deformation Due to Compressive Stress 8652 8652
Appropriate Term/Code Not Available 8349 8351
Protective Measures Problem 7829 7839
Communication or Transmission Problem 6723 6724
Excess Flow or Over-Infusion 6585 6597
Computer Software Problem 6422 6422
False Alarm 6341 6341
Calibration Problem 6330 6330
Peeled/Delaminated 6047 6047
Electrical /Electronic Property Problem 5929 5929
Failure to Infuse 5925 5951
Improper Flow or Infusion 5903 5911
Insufficient Flow or Under Infusion 5668 5672
Misassembled 4924 4924
Naturally Worn 4710 4710
Inaccurate Delivery 4675 4700
Obstruction of Flow 4402 4406
Filling Problem 3776 3777
Fluid/Blood Leak 3483 3491
Output Problem 3441 3448
Application Program Freezes, Becomes Nonfunctional 3175 3175
Mechanical Problem 3110 3112
Loose or Intermittent Connection 2742 2743
Misassembly During Maintenance/Repair 2659 2659
Charging Problem 2576 2576
Positioning Problem 2566 2566
Mechanics Altered 2418 2418
Degraded 2386 2386
Infusion or Flow Problem 2383 2412
Use of Device Problem 2114 2114
Audible Prompt/Feedback Problem 2008 2008

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 695319 695415
Insufficient Information 653457 653560
No Patient Involvement 28096 28096
Hyperglycemia 3761 3765
Hypoglycemia 1258 1262
Low Blood Pressure/ Hypotension 1040 1048
No Consequences Or Impact To Patient 961 961
No Information 649 649
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 341 349
High Blood Pressure/ Hypertension 309 309
Cardiac Arrest 267 267
Diabetic Ketoacidosis 196 196
Nausea 179 181
Headache 160 162
Dyspnea 157 164
Pain 137 139
Vomiting 127 127
Tachycardia 123 124
Hemorrhage/Bleeding 123 123
Fatigue 121 123
Loss of consciousness 102 103
Dizziness 101 103
Bradycardia 95 97
Malaise 70 72
Chest Pain 67 68
Confusion/ Disorientation 61 61
Discomfort 59 59
Anxiety 58 61
Swelling/ Edema 55 55
Diarrhea 54 54
Abdominal Pain 54 54
Urethral Stenosis/Stricture 52 52
Low Oxygen Saturation 48 48
Shaking/Tremors 46 46
Arrhythmia 42 42
Reaction to Medicinal Component of Device 41 41
Hot Flashes/Flushes 39 39
Polydipsia 37 37
Skin Inflammation/ Irritation 34 37
Awareness during Anaesthesia 34 34
Respiratory Arrest 32 32
Muscle Weakness 32 32
Oversedation 31 32
Renal Impairment 30 30
Fetal Distress 29 29
Irritability 28 29
Hypersensitivity/Allergic reaction 28 30
Abdominal Distention 27 27
Coagulation Disorder 27 27
Syncope/Fainting 27 27

Recalls
Manufacturer Recall Class Date Posted
1 Avanos Medical, Inc. II Jun-06-2023
2 B Braun Medical Inc I Sep-07-2024
3 B Braun Medical Inc II Jul-25-2024
4 B. Braun Medical, Inc. I Oct-25-2023
5 Baxter Healthcare Corporation II Feb-13-2026
6 Baxter Healthcare Corporation II Jan-16-2026
7 Baxter Healthcare Corporation I Aug-29-2025
8 Baxter Healthcare Corporation II Aug-22-2025
9 Baxter Healthcare Corporation I Aug-14-2025
10 Baxter Healthcare Corporation II Jun-12-2025
11 Baxter Healthcare Corporation I May-20-2025
12 Baxter Healthcare Corporation II Mar-21-2025
13 Baxter Healthcare Corporation I Mar-06-2025
14 Baxter Healthcare Corporation II Dec-27-2024
15 Baxter Healthcare Corporation II Nov-08-2024
16 Baxter Healthcare Corporation II Aug-16-2024
17 Baxter Healthcare Corporation II Aug-07-2024
18 Baxter Healthcare Corporation II May-13-2024
19 Baxter Healthcare Corporation II May-03-2024
20 Baxter Healthcare Corporation I Nov-09-2023
21 Baxter Healthcare Corporation I Jul-13-2023
22 Baxter Healthcare Corporation I Jan-29-2022
23 Baxter Healthcare Corporation I Aug-11-2021
24 Baxter Healthcare Corporation I Aug-06-2021
25 Baxter Healthcare Corporation II Apr-23-2021
26 Baxter Healthcare Corporation II Feb-25-2021
27 Bayer Medical Care, Inc. II Jan-06-2023
28 Belmont Instrument LLC II Feb-04-2025
29 BioMedical Equipment Service Co (BMES) I Aug-06-2021
30 CareFusion 303, Inc. II Mar-26-2026
31 CareFusion 303, Inc. II Jan-29-2026
32 CareFusion 303, Inc. I Nov-20-2025
33 CareFusion 303, Inc. I Aug-06-2025
34 CareFusion 303, Inc. II Feb-24-2025
35 CareFusion 303, Inc. II Sep-13-2024
36 CareFusion 303, Inc. II Jul-03-2024
37 CareFusion 303, Inc. I Nov-07-2023
38 CareFusion 303, Inc. II Mar-01-2023
39 CareFusion 303, Inc. I Apr-01-2021
40 EITAN MEDICAL LTD I Oct-20-2023
41 Fresenius Kabi USA, LLC II Jan-12-2026
42 Fresenius Kabi USA, LLC I Dec-16-2025
43 Fresenius Kabi USA, LLC I Dec-03-2025
44 Fresenius Kabi USA, LLC II Dec-01-2025
45 Fresenius Kabi USA, LLC II Oct-28-2025
46 Fresenius Kabi USA, LLC II Aug-01-2025
47 Fresenius Kabi USA, LLC I Feb-04-2025
48 Fresenius Kabi USA, LLC I Jan-08-2025
49 Fresenius Kabi USA, LLC I Sep-26-2024
50 Fresenius Kabi USA, LLC I Apr-11-2024
51 Fresenius Kabi USA, LLC II Mar-11-2024
52 Fresenius Kabi USA, LLC II Mar-11-2024
53 Fresenius Kabi USA, LLC I Dec-20-2023
54 Fresenius Kabi USA, LLC II Sep-25-2023
55 Fresenius Kabi USA, LLC I Apr-18-2023
56 ICU Medical Inc I Aug-09-2024
57 ICU Medical Inc II Aug-18-2023
58 ICU Medical Inc I May-16-2023
59 ICU Medical, Inc. II Jan-16-2026
60 ICU Medical, Inc. II Jan-15-2026
61 ICU Medical, Inc. I Aug-06-2025
62 ICU Medical, Inc. II Jun-18-2025
63 ICU Medical, Inc. I Nov-21-2024
64 InfuTronix LLC I Mar-28-2024
65 InfuTronix LLC II Mar-29-2022
66 Infusion Pump Repair I May-10-2021
67 Iradimed Corporation II Mar-30-2023
68 OptumHealth Care Solutions LLC I May-21-2024
69 Pacific Medical Group Inc. I Apr-19-2021
70 STEP-HAR MEDICAL LLC I May-10-2021
71 Smiths Medical ASD Inc. I Oct-31-2024
72 Smiths Medical ASD Inc. I Aug-03-2024
73 Smiths Medical ASD Inc. II Apr-15-2024
74 Smiths Medical ASD Inc. I Feb-01-2024
75 Smiths Medical ASD Inc. I Feb-01-2024
76 Smiths Medical ASD Inc. II Oct-06-2023
77 Smiths Medical ASD Inc. II Nov-21-2022
78 Smiths Medical ASD Inc. I Jun-21-2022
79 Smiths Medical ASD Inc. II Feb-17-2022
80 Smiths Medical ASD Inc. I Oct-19-2021
81 Smiths Medical ASD, Inc. I May-07-2025
82 Smiths Medical ASD, Inc. I May-05-2025
83 Tenacore LLC I Apr-02-2021
84 The Biomed Guys I Jun-01-2021
85 Zyno Medical LLC I Jun-06-2025
86 Zyno Medical LLC III Nov-22-2024
87 Zyno Medical LLC II Nov-21-2024
88 Zyno Medical LLC I Oct-09-2024
89 Zyno Medical LLC II Jul-03-2024
90 Zyno Medical LLC II Feb-23-2024
-
-