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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
CAREFUSION 303 INC.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH & DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
EITAN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVENIX, 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 1

MDR Year MDR Reports MDR Events
2019 15848 15848
2020 94181 94181
2021 199322 199322
2022 888024 888024
2023 165846 165845
2024 39344 39344

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 731655 731655
Corroded 203895 203895
Break 127487 127487
Display Difficult to Read 90129 90129
Device Sensing Problem 53020 53020
Failure to Read Input Signal 52590 52590
Contamination 33003 33003
Device Alarm System 32287 32287
No Apparent Adverse Event 23476 23476
Physical Resistance/Sticking 20134 20134
Display or Visual Feedback Problem 18588 18588
Appropriate Term/Code Not Available 16303 16303
Failure to Calibrate 15763 15763
Battery Problem 14421 14421
Circuit Failure 14302 14302
Electrical /Electronic Property Problem 14123 14123
Insufficient Information 13089 13089
No Display/Image 11872 11872
Failure to Align 10466 10466
Premature Discharge of Battery 9798 9798
Computer Software Problem 8659 8659
Communication or Transmission Problem 8160 8160
Insufficient Flow or Under Infusion 7860 7860
False Alarm 7828 7828
Excess Flow or Over-Infusion 7819 7819
Misassembled 7608 7608
Protective Measures Problem 6809 6809
Deformation Due to Compressive Stress 5494 5494
Naturally Worn 5470 5470
Failure to Sense 5446 5446
Mechanics Altered 5262 5262
Peeled/Delaminated 5030 5030
Improper Flow or Infusion 4666 4666
Application Program Freezes, Becomes Nonfunctional 4408 4408
Obstruction of Flow 4048 4048
Inaccurate Delivery 3891 3891
Failure to Power Up 3568 3568
Output Problem 3382 3382
Fluid/Blood Leak 3355 3355
Calibration Problem 3228 3228
Charging Problem 3191 3191
Defective Alarm 3125 3125
Mechanical Problem 3085 3085
Infusion or Flow Problem 2679 2678
Loose or Intermittent Connection 2519 2519
Positioning Problem 2511 2511
Misassembly During Maintenance/Repair 2492 2492
Audible Prompt/Feedback Problem 2261 2261
Filling Problem 2162 2162
Pumping Stopped 2000 2000

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 651550 651550
No Clinical Signs, Symptoms or Conditions 615103 615102
No Patient Involvement 112917 112919
No Consequences Or Impact To Patient 13314 13324
No Information 7148 7150
Hyperglycemia 5295 5295
Hypoglycemia 2758 2758
No Known Impact Or Consequence To Patient 2162 2162
Low Blood Pressure/ Hypotension 919 919
Diabetic Ketoacidosis 503 503
Nausea 449 449
Vomiting 336 336
High Blood Pressure/ Hypertension 261 261
Cardiac Arrest 257 257
Dyspnea 230 230
Loss of consciousness 201 201
Headache 199 199
Abdominal Pain 174 174
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 158 158
Pain 157 157
Death 134 134
Fatigue 126 126
Bradycardia 119 119
Tachycardia 106 106
Dizziness 99 99
Overdose 91 91
No Code Available 85 85
Shaking/Tremors 67 67
Confusion/ Disorientation 67 67
Anxiety 63 63
Chest Pain 61 61
Diarrhea 59 59
Discomfort 58 58
Polydipsia 56 56
Urethral Stenosis/Stricture 52 52
Hemorrhage/Bleeding 50 50
Blood Loss 49 49
Therapeutic Response, Increased 47 47
Low Oxygen Saturation 45 45
Malaise 43 43
Coma 42 42
Arrhythmia 40 41
Seizures 40 40
Oversedation 37 37
Lethargy 35 35
Hypoxia 35 35
Underdose 34 34
Swelling/ Edema 33 33
Hot Flashes/Flushes 33 33
Fetal Distress 32 32

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-16-2024
6 Baxter Healthcare Corporation II Aug-07-2024
7 Baxter Healthcare Corporation II May-13-2024
8 Baxter Healthcare Corporation II May-03-2024
9 Baxter Healthcare Corporation I Nov-09-2023
10 Baxter Healthcare Corporation I Jul-13-2023
11 Baxter Healthcare Corporation I Jan-29-2022
12 Baxter Healthcare Corporation I Aug-11-2021
13 Baxter Healthcare Corporation I Aug-06-2021
14 Baxter Healthcare Corporation II Apr-23-2021
15 Baxter Healthcare Corporation II Feb-25-2021
16 Baxter Healthcare Corporation II Dec-23-2020
17 Baxter Healthcare Corporation I Oct-22-2020
18 Baxter Healthcare Corporation II May-02-2019
19 Bayer Medical Care, Inc. II Jan-06-2023
20 BioMedical Equipment Service Co (BMES) I Aug-06-2021
21 CME America LLC II Oct-29-2020
22 CME America, LLC II Dec-03-2020
23 CME America, LLC I Mar-18-2020
24 CME America, LLC I Mar-11-2020
25 CareFusion 303, Inc. II Sep-13-2024
26 CareFusion 303, Inc. II Jul-03-2024
27 CareFusion 303, Inc. I Nov-07-2023
28 CareFusion 303, Inc. II Mar-01-2023
29 CareFusion 303, Inc. I Apr-01-2021
30 CareFusion 303, Inc. I Sep-12-2020
31 CareFusion 303, Inc. I Sep-04-2020
32 CareFusion 303, Inc. I Sep-04-2020
33 CareFusion 303, Inc. II Aug-19-2020
34 CareFusion 303, Inc. I Aug-06-2020
35 CareFusion 303, Inc. I Aug-06-2020
36 CareFusion 303, Inc. I Aug-06-2020
37 CareFusion 303, Inc. I Mar-05-2020
38 CareFusion 303, Inc. I Jul-16-2019
39 EITAN MEDICAL LTD I Oct-20-2023
40 Fenwal Inc I Aug-12-2019
41 Fresenius Kabi USA, LLC I Apr-11-2024
42 Fresenius Kabi USA, LLC II Mar-11-2024
43 Fresenius Kabi USA, LLC II Mar-11-2024
44 Fresenius Kabi USA, LLC I Dec-20-2023
45 Fresenius Kabi USA, LLC II Sep-25-2023
46 Fresenius Kabi USA, LLC I Apr-18-2023
47 ICU Medical Inc I Aug-09-2024
48 ICU Medical Inc II Aug-18-2023
49 ICU Medical Inc I May-16-2023
50 ICU Medical Inc II Oct-22-2019
51 ICU Medical Inc II Oct-14-2019
52 InfuTronix LLC I Mar-28-2024
53 InfuTronix LLC II Mar-29-2022
54 InfuTronix LLC II Jul-23-2019
55 Infusion Pump Repair I May-10-2021
56 Iradimed Corporation II Mar-30-2023
57 OptumHealth Care Solutions LLC I May-21-2024
58 Pacific Medical Group Inc. I Apr-19-2021
59 STEP-HAR MEDICAL LLC I May-10-2021
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 Smiths Medical ASD Inc. I Dec-12-2019
71 Tenacore LLC I Apr-02-2021
72 The Biomed Guys I Jun-01-2021
73 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019
74 Zyno Medical LLC II Jul-03-2024
75 Zyno Medical LLC II Feb-23-2024
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