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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
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
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 53487 53487

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 711646 711648
Corroded 198788 198789
Break 119889 119893
Display Difficult to Read 89646 89646
Device Sensing Problem 53688 53688
Failure to Read Input Signal 50569 50569
Contamination 31867 31868
Device Alarm System 29289 29313
No Apparent Adverse Event 19360 19361
Physical Resistance/Sticking 17835 17835
Failure to Calibrate 14568 14568
Battery Problem 14350 14353
No Display/Image 11109 11110
Circuit Failure 10857 10857
Failure to Align 10336 10336
Premature Discharge of Battery 10263 10264
Failure to Sense 10103 10103
Insufficient Information 9948 9948
Display or Visual Feedback Problem 9310 9313
Deformation Due to Compressive Stress 8371 8371
Appropriate Term/Code Not Available 8318 8320
Protective Measures Problem 7594 7604
Communication or Transmission Problem 6671 6672
Computer Software Problem 6412 6412
Excess Flow or Over-Infusion 6190 6202
False Alarm 6076 6076
Peeled/Delaminated 5916 5916
Electrical /Electronic Property Problem 5796 5796
Calibration Problem 5539 5539
Insufficient Flow or Under Infusion 5365 5369
Failure to Infuse 5227 5253
Improper Flow or Infusion 5135 5143
Misassembled 4813 4813
Naturally Worn 4564 4564
Inaccurate Delivery 4502 4527
Obstruction of Flow 4187 4191
Filling Problem 3479 3480
Output Problem 3332 3339
Application Program Freezes, Becomes Nonfunctional 3167 3167
Fluid/Blood Leak 3119 3127
Mechanical Problem 2993 2995
Misassembly During Maintenance/Repair 2627 2627
Loose or Intermittent Connection 2602 2603
Positioning Problem 2566 2566
Charging Problem 2512 2512
Mechanics Altered 2417 2417
Degraded 2331 2331
Infusion or Flow Problem 2248 2277
Audible Prompt/Feedback Problem 2005 2005
Use of Device Problem 1949 1949

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 678696 678791
Insufficient Information 653069 653172
No Patient Involvement 28096 28096
Hyperglycemia 3391 3395
Hypoglycemia 1221 1225
Low Blood Pressure/ Hypotension 997 1005
No Consequences Or Impact To Patient 961 961
No Information 649 649
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 324 332
High Blood Pressure/ Hypertension 292 292
Cardiac Arrest 253 253
Diabetic Ketoacidosis 191 191
Nausea 176 178
Dyspnea 155 162
Headache 154 156
Pain 132 134
Vomiting 124 124
Fatigue 116 118
Tachycardia 110 111
Hemorrhage/Bleeding 103 103
Loss of consciousness 100 101
Dizziness 97 99
Bradycardia 91 93
Malaise 60 62
Chest Pain 60 61
Confusion/ Disorientation 60 60
Discomfort 58 58
Anxiety 55 58
Diarrhea 54 54
Abdominal Pain 53 53
Urethral Stenosis/Stricture 52 52
Swelling/ Edema 48 48
Shaking/Tremors 46 46
Low Oxygen Saturation 43 43
Arrhythmia 41 41
Polydipsia 37 37
Hot Flashes/Flushes 36 36
Skin Inflammation/ Irritation 32 35
Renal Impairment 30 30
Respiratory Arrest 30 30
Oversedation 30 31
Fetal Distress 29 29
Muscle Weakness 28 28
Awareness during Anaesthesia 28 28
Irritability 28 29
Abdominal Distention 27 27
Syncope/Fainting 27 27
Hypersensitivity/Allergic reaction 26 28
Coagulation Disorder 26 26
Fever 25 25

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