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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
  1.  K211122  Novum IQ Large Volume Pump
  2.  K211125  Novum IQ Syringe Pump
  3.  K220417  Spectrum IQ Infusion System with Dose IQ Safety So ...
  4.  K222048  Spectrum IQ Infusion System with Dose IQ Safety So ...
  5.  K230022  Baxter SIGMA Spectrum Infusion Pump with Master Dr ...
  6.  K230041  Spectrum IQ Infusion System with Dose IQ Safety So ...
  7.  K242390  Novum IQ Syringe Pump (40800BAXUS)
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 57737 57738
2025 4140 4140

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 732671 732671
Corroded 206624 206624
Break 129914 129914
Display Difficult to Read 90938 90938
Device Sensing Problem 55804 55804
Failure to Read Input Signal 53366 53366
Contamination 34194 34194
Device Alarm System 30553 30553
No Apparent Adverse Event 23650 23650
Physical Resistance/Sticking 20830 20830
Display or Visual Feedback Problem 18664 18664
Appropriate Term/Code Not Available 16178 16178
Failure to Calibrate 15837 15837
Circuit Failure 14751 14751
Battery Problem 14413 14413
Electrical /Electronic Property Problem 14275 14275
Insufficient Information 12972 12972
No Display/Image 11787 11787
Failure to Align 10435 10435
Deformation Due to Compressive Stress 10198 10198
Premature Discharge of Battery 9943 9943
Computer Software Problem 8534 8534
Communication or Transmission Problem 8176 8176
Misassembled 7700 7700
Protective Measures Problem 7179 7179
False Alarm 6770 6770
Excess Flow or Over-Infusion 6717 6717
Insufficient Flow or Under Infusion 6500 6500
Failure to Sense 6233 6233
Naturally Worn 5733 5733
Peeled/Delaminated 5533 5533
Mechanics Altered 5264 5264
Application Program Freezes, Becomes Nonfunctional 4398 4398
Improper Flow or Infusion 4396 4396
Inaccurate Delivery 4032 4032
Obstruction of Flow 4030 4030
Calibration Problem 3884 3884
Output Problem 3679 3679
Failure to Power Up 3579 3579
Charging Problem 3223 3223
Mechanical Problem 3027 3027
Defective Alarm 2868 2868
Fluid/Blood Leak 2843 2843
Failure to Infuse 2800 2800
Loose or Intermittent Connection 2581 2581
Misassembly During Maintenance/Repair 2543 2543
Positioning Problem 2522 2522
Infusion or Flow Problem 2505 2504
Filling Problem 2414 2414
Audible Prompt/Feedback Problem 2249 2249

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 652040 652040
No Clinical Signs, Symptoms or Conditions 636473 636473
No Patient Involvement 108041 108043
No Consequences Or Impact To Patient 8029 8039
No Information 5306 5308
Hyperglycemia 3940 3940
Hypoglycemia 2007 2007
Low Blood Pressure/ Hypotension 951 951
No Known Impact Or Consequence To Patient 388 388
Nausea 308 308
Diabetic Ketoacidosis 302 302
High Blood Pressure/ Hypertension 275 275
Cardiac Arrest 259 259
Vomiting 236 236
Dyspnea 192 192
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 181 181
Headache 165 165
Loss of consciousness 151 151
Pain 131 131
Fatigue 124 124
Abdominal Pain 110 110
Bradycardia 107 107
Tachycardia 103 103
Dizziness 95 95
Death 67 67
Confusion/ Disorientation 67 67
Shaking/Tremors 65 65
Chest Pain 61 61
Anxiety 60 60
Hemorrhage/Bleeding 57 57
Discomfort 56 56
Overdose 56 56
Diarrhea 54 54
Polydipsia 53 53
Urethral Stenosis/Stricture 52 52
Malaise 52 52
Low Oxygen Saturation 43 43
No Code Available 42 42
Swelling/ Edema 40 40
Arrhythmia 36 37
Hypoxia 33 33
Coma 32 32
Fetal Distress 32 32
Underdose 32 32
Hot Flashes/Flushes 31 31
Oversedation 31 31
Lethargy 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 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 Belmont Instrument LLC II Feb-04-2025
22 BioMedical Equipment Service Co (BMES) I Aug-06-2021
23 CME America LLC II Oct-29-2020
24 CME America, LLC II Dec-03-2020
25 CME America, LLC I Mar-18-2020
26 CME America, LLC I Mar-11-2020
27 CareFusion 303, Inc. II Sep-13-2024
28 CareFusion 303, Inc. II Jul-03-2024
29 CareFusion 303, Inc. I Nov-07-2023
30 CareFusion 303, Inc. II Mar-01-2023
31 CareFusion 303, Inc. I Apr-01-2021
32 CareFusion 303, Inc. I Sep-12-2020
33 CareFusion 303, Inc. I Sep-04-2020
34 CareFusion 303, Inc. I Sep-04-2020
35 CareFusion 303, Inc. II Aug-19-2020
36 CareFusion 303, Inc. I Aug-06-2020
37 CareFusion 303, Inc. I Aug-06-2020
38 CareFusion 303, Inc. I Aug-06-2020
39 CareFusion 303, Inc. I Mar-05-2020
40 EITAN MEDICAL LTD I Oct-20-2023
41 Fresenius Kabi USA, LLC I Feb-04-2025
42 Fresenius Kabi USA, LLC I Jan-08-2025
43 Fresenius Kabi USA, LLC I Sep-26-2024
44 Fresenius Kabi USA, LLC I Apr-11-2024
45 Fresenius Kabi USA, LLC II Mar-11-2024
46 Fresenius Kabi USA, LLC II Mar-11-2024
47 Fresenius Kabi USA, LLC I Dec-20-2023
48 Fresenius Kabi USA, LLC II Sep-25-2023
49 Fresenius Kabi USA, LLC I Apr-18-2023
50 ICU Medical Inc I Aug-09-2024
51 ICU Medical Inc II Aug-18-2023
52 ICU Medical Inc I May-16-2023
53 ICU Medical, Inc. I Nov-21-2024
54 InfuTronix LLC I Mar-28-2024
55 InfuTronix LLC II Mar-29-2022
56 Infusion Pump Repair I May-10-2021
57 Iradimed Corporation II Mar-30-2023
58 OptumHealth Care Solutions LLC I May-21-2024
59 Pacific Medical Group Inc. I Apr-19-2021
60 STEP-HAR MEDICAL LLC I May-10-2021
61 Smiths Medical ASD Inc. I Oct-31-2024
62 Smiths Medical ASD Inc. I Aug-03-2024
63 Smiths Medical ASD Inc. II Apr-15-2024
64 Smiths Medical ASD Inc. I Feb-01-2024
65 Smiths Medical ASD Inc. I Feb-01-2024
66 Smiths Medical ASD Inc. II Oct-06-2023
67 Smiths Medical ASD Inc. II Nov-21-2022
68 Smiths Medical ASD Inc. I Jun-21-2022
69 Smiths Medical ASD Inc. II Feb-17-2022
70 Smiths Medical ASD Inc. I Oct-19-2021
71 Smiths Medical ASD Inc. I Aug-06-2020
72 Tenacore LLC I Apr-02-2021
73 The Biomed Guys I Jun-01-2021
74 Zyno Medical LLC III Nov-22-2024
75 Zyno Medical LLC II Nov-21-2024
76 Zyno Medical LLC I Oct-09-2024
77 Zyno Medical LLC II Jul-03-2024
78 Zyno Medical LLC II Feb-23-2024
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