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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 7
BELMONT MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303 INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 303, INC.
  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 1
ICU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KORU MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDOVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
Q CORE MEDICAL LTD.
  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
2020 94181 94181
2021 199322 199322
2022 888021 888021
2023 165843 165842
2024 57734 57735
2025 12902 12902

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 733167 733167
Corroded 207221 207221
Break 131054 131054
Display Difficult to Read 91127 91127
Device Sensing Problem 57045 57045
Failure to Read Input Signal 53556 53556
Contamination 34562 34562
Device Alarm System 31362 31362
No Apparent Adverse Event 24189 24189
Physical Resistance/Sticking 20965 20965
Display or Visual Feedback Problem 18714 18714
Appropriate Term/Code Not Available 16188 16188
Failure to Calibrate 15855 15855
Circuit Failure 15004 15004
Battery Problem 14465 14465
Electrical /Electronic Property Problem 14347 14347
Insufficient Information 12980 12980
No Display/Image 11822 11822
Failure to Align 10457 10457
Deformation Due to Compressive Stress 10366 10366
Premature Discharge of Battery 10112 10112
Computer Software Problem 8539 8539
Communication or Transmission Problem 8246 8246
Misassembled 7708 7708
Protective Measures Problem 7400 7400
False Alarm 6957 6957
Excess Flow or Over-Infusion 6924 6924
Failure to Sense 6895 6895
Insufficient Flow or Under Infusion 6666 6666
Peeled/Delaminated 5817 5817
Naturally Worn 5811 5811
Mechanics Altered 5264 5264
Improper Flow or Infusion 4550 4550
Application Program Freezes, Becomes Nonfunctional 4400 4400
Inaccurate Delivery 4192 4192
Calibration Problem 4124 4124
Obstruction of Flow 4118 4118
Output Problem 3772 3772
Failure to Power Up 3585 3585
Failure to Infuse 3337 3337
Charging Problem 3249 3249
Mechanical Problem 3078 3078
Defective Alarm 2925 2925
Fluid/Blood Leak 2916 2916
Filling Problem 2778 2778
Loose or Intermittent Connection 2649 2649
Misassembly During Maintenance/Repair 2566 2566
Infusion or Flow Problem 2543 2542
Positioning Problem 2526 2526
Audible Prompt/Feedback Problem 2250 2250

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 652306 652306
No Clinical Signs, Symptoms or Conditions 644779 644779
No Patient Involvement 108041 108043
No Consequences Or Impact To Patient 8029 8039
No Information 5306 5308
Hyperglycemia 4026 4026
Hypoglycemia 2019 2019
Low Blood Pressure/ Hypotension 986 986
No Known Impact Or Consequence To Patient 388 388
Nausea 309 309
Diabetic Ketoacidosis 303 303
High Blood Pressure/ Hypertension 290 290
Cardiac Arrest 261 261
Vomiting 237 237
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 203 203
Dyspnea 196 196
Headache 166 166
Loss of consciousness 152 152
Pain 138 138
Fatigue 128 128
Abdominal Pain 112 112
Tachycardia 108 108
Bradycardia 107 107
Dizziness 102 102
Confusion/ Disorientation 67 67
Death 67 67
Shaking/Tremors 66 66
Anxiety 64 64
Chest Pain 63 63
Diarrhea 59 59
Hemorrhage/Bleeding 59 59
Overdose 56 56
Discomfort 56 56
Malaise 53 53
Polydipsia 53 53
Urethral Stenosis/Stricture 52 52
Low Oxygen Saturation 44 44
No Code Available 42 42
Swelling/ Edema 40 40
Arrhythmia 37 38
Hot Flashes/Flushes 36 36
Hypoxia 34 34
Fetal Distress 33 33
Coma 32 32
Underdose 32 32
Lethargy 31 31
Oversedation 31 31
Renal Impairment 30 30
Abdominal Distention 30 30
Respiratory Arrest 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 Mar-21-2025
6 Baxter Healthcare Corporation I Mar-06-2025
7 Baxter Healthcare Corporation II Dec-27-2024
8 Baxter Healthcare Corporation II Nov-08-2024
9 Baxter Healthcare Corporation II Aug-16-2024
10 Baxter Healthcare Corporation II Aug-07-2024
11 Baxter Healthcare Corporation II May-13-2024
12 Baxter Healthcare Corporation II May-03-2024
13 Baxter Healthcare Corporation I Nov-09-2023
14 Baxter Healthcare Corporation I Jul-13-2023
15 Baxter Healthcare Corporation I Jan-29-2022
16 Baxter Healthcare Corporation I Aug-11-2021
17 Baxter Healthcare Corporation I Aug-06-2021
18 Baxter Healthcare Corporation II Apr-23-2021
19 Baxter Healthcare Corporation II Feb-25-2021
20 Baxter Healthcare Corporation II Dec-23-2020
21 Baxter Healthcare Corporation I Oct-22-2020
22 Bayer Medical Care, Inc. II Jan-06-2023
23 Belmont Instrument LLC II Feb-04-2025
24 BioMedical Equipment Service Co (BMES) I Aug-06-2021
25 CME America LLC II Oct-29-2020
26 CME America, LLC II Dec-03-2020
27 CME America, LLC I Mar-18-2020
28 CME America, LLC I Mar-11-2020
29 CareFusion 303, Inc. II Feb-24-2025
30 CareFusion 303, Inc. II Sep-13-2024
31 CareFusion 303, Inc. II Jul-03-2024
32 CareFusion 303, Inc. I Nov-07-2023
33 CareFusion 303, Inc. II Mar-01-2023
34 CareFusion 303, Inc. I Apr-01-2021
35 CareFusion 303, Inc. I Sep-12-2020
36 CareFusion 303, Inc. I Sep-04-2020
37 CareFusion 303, Inc. I Sep-04-2020
38 CareFusion 303, Inc. II Aug-19-2020
39 CareFusion 303, Inc. I Aug-06-2020
40 CareFusion 303, Inc. I Aug-06-2020
41 CareFusion 303, Inc. I Aug-06-2020
42 CareFusion 303, Inc. I Mar-05-2020
43 EITAN MEDICAL LTD I Oct-20-2023
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. I Nov-21-2024
57 InfuTronix LLC I Mar-28-2024
58 InfuTronix LLC II Mar-29-2022
59 Infusion Pump Repair I May-10-2021
60 Iradimed Corporation II Mar-30-2023
61 OptumHealth Care Solutions LLC I May-21-2024
62 Pacific Medical Group Inc. I Apr-19-2021
63 STEP-HAR MEDICAL LLC I May-10-2021
64 Smiths Medical ASD Inc. I Oct-31-2024
65 Smiths Medical ASD Inc. I Aug-03-2024
66 Smiths Medical ASD Inc. II Apr-15-2024
67 Smiths Medical ASD Inc. I Feb-01-2024
68 Smiths Medical ASD Inc. I Feb-01-2024
69 Smiths Medical ASD Inc. II Oct-06-2023
70 Smiths Medical ASD Inc. II Nov-21-2022
71 Smiths Medical ASD Inc. I Jun-21-2022
72 Smiths Medical ASD Inc. II Feb-17-2022
73 Smiths Medical ASD Inc. I Oct-19-2021
74 Smiths Medical ASD Inc. I Aug-06-2020
75 Tenacore LLC I Apr-02-2021
76 The Biomed Guys I Jun-01-2021
77 Zyno Medical LLC III Nov-22-2024
78 Zyno Medical LLC II Nov-21-2024
79 Zyno Medical LLC I Oct-09-2024
80 Zyno Medical LLC II Jul-03-2024
81 Zyno Medical LLC II Feb-23-2024
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