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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 R&D CORP
  SUBSTANTIALLY EQUIVALENT 1
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 53486 53486
2026 35115 35117

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 712446 712446
Corroded 200407 200408
Break 123315 123315
Display Difficult to Read 89921 89921
Device Sensing Problem 59024 59024
Failure to Read Input Signal 50749 50749
Contamination 33341 33342
Device Alarm System 32823 32833
No Apparent Adverse Event 23579 23580
Physical Resistance/Sticking 18289 18289
Battery Problem 14607 14608
Failure to Calibrate 14565 14565
Failure to Sense 13713 13714
Circuit Failure 11912 11912
No Display/Image 11181 11181
Premature Discharge of Battery 10610 10610
Failure to Align 10422 10422
Insufficient Device Problem Information 9909 9909
Display or Visual Feedback Problem 9740 9740
Deformation Due to Compressive Stress 8929 8929
Appropriate Device Problem Term/Code Not Available 8267 8269
Protective Measures Problem 7728 7728
Calibration Problem 7105 7105
Communication or Transmission Problem 6849 6849
Excess Flow or Over-Infusion 6805 6807
Failure to Infuse 6768 6769
False Alarm 6660 6660
Improper Flow or Infusion 6376 6377
Peeled/Delaminated 6137 6137
Computer Software Problem 6130 6130
Electrical /Electronic Property Problem 6010 6010
Insufficient Flow or Under Infusion 5869 5872
Misassembled 4927 4927
Naturally Worn 4833 4833
Inaccurate Delivery 4803 4803
Obstruction of Flow 4402 4406
Filling Problem 4041 4042
Fluid/Blood Leak 3714 3716
Output Problem 3458 3458
Mechanical Problem 3208 3209
Application Program Freezes or Fails to Launch 3161 3161
Loose or Intermittent Connection 2800 2800
Misassembly During Maintenance/Repair 2690 2690
Charging Problem 2624 2624
Positioning Problem 2563 2563
Degraded 2394 2394
Mechanics Altered 2376 2376
Use of Device Problem 2254 2254
Infusion or Flow Problem 2244 2245
Defective Alarm 2025 2025

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 711990 712087
Insufficient Information 653823 653926
No Patient Involvement 28096 28096
Hyperglycemia 4059 4063
Hypoglycemia 1285 1289
Low Blood Pressure/ Hypotension 1102 1110
No Consequences Or Impact To Patient 961 961
No Information 649 649
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 379 387
High Blood Pressure/ Hypertension 334 334
Cardiac Arrest 276 276
Elevated ketones/Diabetic Ketoacidosis 197 197
Nausea 187 189
Headache 169 171
Dyspnea 167 174
Pain 148 150
Tachycardia 144 145
Vomiting 134 134
Hemorrhage/Blood Loss/Bleeding 128 128
Fatigue 126 128
Dizziness 109 111
Bradycardia 107 109
Loss of consciousness 103 104
Malaise 78 80
Chest Pain 74 75
Discomfort 64 64
Swelling/ Edema 61 61
Confusion/ Disorientation 61 61
Anxiety 60 63
Diarrhea 55 55
Abdominal Pain 55 55
Urethral Stenosis/Stricture 52 52
Low Oxygen Saturation 51 51
Shaking/Tremors 49 49
Arrhythmia 46 46
Hypersensitivity/Allergic reaction 42 44
Reaction to Medicinal Component of Device 42 42
Hot Flashes/Flushes 41 41
Polydipsia 37 37
Skin Inflammation/ Irritation 36 39
Hypoxia 34 34
Awareness during Anaesthesia 34 34
Muscle Weakness/Atrophy 32 32
Respiratory Arrest 32 32
Fetal Distress 31 31
Oversedation 31 32
Hemodynamic instability 31 31
Irritability 30 31
Renal Impairment 30 30
Convulsion/Seizure 29 29

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