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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion
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
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
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 888024 888024
2023 165843 165842
2024 57741 57742

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 732421 732421
Corroded 206250 206250
Break 129406 129406
Display Difficult to Read 90881 90881
Device Sensing Problem 55264 55264
Failure to Read Input Signal 53244 53244
Contamination 33959 33959
Device Alarm System 30192 30192
No Apparent Adverse Event 23528 23528
Physical Resistance/Sticking 20761 20761
Display or Visual Feedback Problem 18638 18638
Appropriate Term/Code Not Available 16159 16159
Failure to Calibrate 15828 15828
Circuit Failure 14631 14631
Battery Problem 14385 14385
Electrical /Electronic Property Problem 14242 14242
Insufficient Information 12970 12970
No Display/Image 11783 11783
Failure to Align 10427 10427
Deformation Due to Compressive Stress 10118 10118
Premature Discharge of Battery 9898 9898
Computer Software Problem 8532 8532
Communication or Transmission Problem 8141 8141
Misassembled 7691 7691
Protective Measures Problem 7094 7094
False Alarm 6695 6695
Excess Flow or Over-Infusion 6625 6625
Insufficient Flow or Under Infusion 6430 6430
Failure to Sense 5981 5981
Naturally Worn 5697 5697
Peeled/Delaminated 5436 5436
Mechanics Altered 5263 5263
Application Program Freezes, Becomes Nonfunctional 4397 4397
Improper Flow or Infusion 4271 4271
Inaccurate Delivery 3969 3969
Obstruction of Flow 3936 3936
Calibration Problem 3743 3743
Output Problem 3647 3647
Failure to Power Up 3569 3569
Charging Problem 3213 3213
Mechanical Problem 3018 3018
Defective Alarm 2844 2844
Fluid/Blood Leak 2779 2779
Loose or Intermittent Connection 2557 2557
Misassembly During Maintenance/Repair 2536 2536
Failure to Infuse 2525 2525
Positioning Problem 2520 2520
Infusion or Flow Problem 2491 2490
Filling Problem 2338 2338
Audible Prompt/Feedback Problem 2248 2248

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 651928 651928
No Clinical Signs, Symptoms or Conditions 632564 632564
No Patient Involvement 108041 108043
No Consequences Or Impact To Patient 8029 8039
No Information 5306 5308
Hyperglycemia 3861 3861
Hypoglycemia 1997 1997
Low Blood Pressure/ Hypotension 935 935
No Known Impact Or Consequence To Patient 388 388
Nausea 306 306
Diabetic Ketoacidosis 300 300
High Blood Pressure/ Hypertension 270 270
Cardiac Arrest 256 256
Vomiting 235 235
Dyspnea 191 191
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 175 175
Headache 165 165
Loss of consciousness 151 151
Pain 129 129
Fatigue 123 123
Abdominal Pain 109 109
Bradycardia 107 107
Tachycardia 102 102
Dizziness 94 94
Death 67 67
Confusion/ Disorientation 66 66
Shaking/Tremors 65 65
Anxiety 60 60
Chest Pain 60 60
Overdose 56 56
Hemorrhage/Bleeding 56 56
Diarrhea 54 54
Discomfort 53 53
Polydipsia 52 52
Urethral Stenosis/Stricture 52 52
Malaise 49 49
Low Oxygen Saturation 43 43
No Code Available 42 42
Swelling/ Edema 40 40
Arrhythmia 36 37
Hypoxia 33 33
Underdose 32 32
Coma 32 32
Oversedation 31 31
Hot Flashes/Flushes 31 31
Fetal Distress 31 31
Lethargy 30 30
Abdominal Distention 30 30
Erythema 28 28
Respiratory Arrest 28 28

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 Dec-27-2024
6 Baxter Healthcare Corporation II Nov-08-2024
7 Baxter Healthcare Corporation II Aug-16-2024
8 Baxter Healthcare Corporation II Aug-07-2024
9 Baxter Healthcare Corporation II May-13-2024
10 Baxter Healthcare Corporation II May-03-2024
11 Baxter Healthcare Corporation I Nov-09-2023
12 Baxter Healthcare Corporation I Jul-13-2023
13 Baxter Healthcare Corporation I Jan-29-2022
14 Baxter Healthcare Corporation I Aug-11-2021
15 Baxter Healthcare Corporation I Aug-06-2021
16 Baxter Healthcare Corporation II Apr-23-2021
17 Baxter Healthcare Corporation II Feb-25-2021
18 Baxter Healthcare Corporation II Dec-23-2020
19 Baxter Healthcare Corporation I Oct-22-2020
20 Bayer Medical Care, Inc. II Jan-06-2023
21 BioMedical Equipment Service Co (BMES) I Aug-06-2021
22 CME America LLC II Oct-29-2020
23 CME America, LLC II Dec-03-2020
24 CME America, LLC I Mar-18-2020
25 CME America, LLC I Mar-11-2020
26 CareFusion 303, Inc. II Sep-13-2024
27 CareFusion 303, Inc. II Jul-03-2024
28 CareFusion 303, Inc. I Nov-07-2023
29 CareFusion 303, Inc. II Mar-01-2023
30 CareFusion 303, Inc. I Apr-01-2021
31 CareFusion 303, Inc. I Sep-12-2020
32 CareFusion 303, Inc. I Sep-04-2020
33 CareFusion 303, Inc. I Sep-04-2020
34 CareFusion 303, Inc. II Aug-19-2020
35 CareFusion 303, Inc. I Aug-06-2020
36 CareFusion 303, Inc. I Aug-06-2020
37 CareFusion 303, Inc. I Aug-06-2020
38 CareFusion 303, Inc. I Mar-05-2020
39 EITAN MEDICAL LTD I Oct-20-2023
40 Fresenius Kabi USA, LLC I Jan-08-2025
41 Fresenius Kabi USA, LLC I Sep-26-2024
42 Fresenius Kabi USA, LLC I Apr-11-2024
43 Fresenius Kabi USA, LLC II Mar-11-2024
44 Fresenius Kabi USA, LLC II Mar-11-2024
45 Fresenius Kabi USA, LLC I Dec-20-2023
46 Fresenius Kabi USA, LLC II Sep-25-2023
47 Fresenius Kabi USA, LLC I Apr-18-2023
48 ICU Medical Inc I Aug-09-2024
49 ICU Medical Inc II Aug-18-2023
50 ICU Medical Inc I May-16-2023
51 ICU Medical, Inc. I Nov-21-2024
52 InfuTronix LLC I Mar-28-2024
53 InfuTronix LLC II Mar-29-2022
54 Infusion Pump Repair I May-10-2021
55 Iradimed Corporation II Mar-30-2023
56 OptumHealth Care Solutions LLC I May-21-2024
57 Pacific Medical Group Inc. I Apr-19-2021
58 STEP-HAR MEDICAL LLC I May-10-2021
59 Smiths Medical ASD Inc. I Oct-31-2024
60 Smiths Medical ASD Inc. I Aug-03-2024
61 Smiths Medical ASD Inc. II Apr-15-2024
62 Smiths Medical ASD Inc. I Feb-01-2024
63 Smiths Medical ASD Inc. I Feb-01-2024
64 Smiths Medical ASD Inc. II Oct-06-2023
65 Smiths Medical ASD Inc. II Nov-21-2022
66 Smiths Medical ASD Inc. I Jun-21-2022
67 Smiths Medical ASD Inc. II Feb-17-2022
68 Smiths Medical ASD Inc. I Oct-19-2021
69 Smiths Medical ASD Inc. I Aug-06-2020
70 Tenacore LLC I Apr-02-2021
71 The Biomed Guys I Jun-01-2021
72 Zyno Medical LLC III Nov-22-2024
73 Zyno Medical LLC II Nov-21-2024
74 Zyno Medical LLC I Oct-09-2024
75 Zyno Medical LLC II Jul-03-2024
76 Zyno Medical LLC II Feb-23-2024
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