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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
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARTICEPT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 27019 27019
2016 16549 16549
2017 12058 12058
2018 16583 16583
2019 15857 15857
2020 24540 24540

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 30731 30731
Device Alarm System 9897 9897
Excess Flow or Over-Infusion 6210 6210
Reservoir 5681 5681
Air Leak 5428 5428
Insufficient Flow or Under Infusion 4959 4959
False Alarm 4378 4378
Device Operates Differently Than Expected 4284 4284
Failure to Deliver 3445 3445
Device Contamination with Chemical or Other Material 3330 3330
Nonstandard Device 3181 3181
Pump 3005 3005
Keypad 2957 2957
Break 2909 2909
Fluid Leak 2610 2610
Electrical /Electronic Property Problem 2524 2524
Adverse Event Without Identified Device or Use Problem 2443 2443
Improper Flow or Infusion 2424 2424
Display or Visual Feedback Problem 2272 2272
Infusion or Flow Problem 2211 2211
Occlusion Within Device 1938 1938
Leak/Splash 1853 1853
Crack 1635 1635
No Apparent Adverse Event 1333 1333
Physical Resistance/Sticking 1329 1329
Defective Alarm 1273 1273
Insufficient Information 1254 1254
Device Sensing Problem 1240 1240
Failure to Sense 1132 1132
Output Problem 1060 1060
Appropriate Term/Code Not Available 1040 1040
Battery Problem 1015 1015
Obstruction of Flow 999 999
Pumping Stopped 999 999
Device Inoperable 826 826
Inaccurate Delivery 777 777
No Display/Image 718 718
Alarm, Audible 675 675
Bent 666 666
Cannula 638 638
Mechanical Problem 628 628
Tube 621 621
Failure to Power Up 610 610
Difficult or Delayed Activation 585 585
Corroded 585 585
Pressure Problem 575 575
Communication or Transmission Problem 569 569
Battery 567 567
Inaccurate Flow Rate 563 563
Alarm 547 547
Free or Unrestricted Flow 527 527
Protective Measures Problem 500 500
No Flow 486 486
Improper or Incorrect Procedure or Method 473 473
Failure to Prime 463 463
Material Rupture 446 446
No Audible Alarm 425 425
Volume Accuracy Problem 424 424
Complete Loss of Power 399 399
Loss of Power 367 367
Defective Component 364 364
Circuit Failure 364 364
Computer Software Problem 330 330
Power Cord 330 330
Connection Problem 330 330
No Audible Prompt/Feedback 327 327
High Test Results 319 319
Filling Problem 318 318
Patient Device Interaction Problem 318 318
Housing 317 317
Failure to Align 306 306
Unexpected Shutdown 303 303
Screen 295 295
Alarm, Visual 294 294
Sensor 277 277
Use of Device Problem 272 272
Power Problem 271 271
Switch, Push Button 265 265
Disconnection 265 265
Motor(s) 260 260
Cap 242 242
Failure to Infuse 240 240
Filter 232 232
Latch 227 227
Thermal Decomposition of Device 224 224
Application Program Freezes, Becomes Nonfunctional 218 218
Device Component Or Accessory 215 215
Failure to Cycle 211 211
Device Difficult to Setup or Prepare 205 205
Physical Resistance 203 203
Noise, Audible 195 195
Component Missing 192 192
Ring 190 190
Sticking 187 187
Calibration Problem 185 185
Plunger 185 185
Cassette 182 182
Material Fragmentation 182 182
Naturally Worn 181 181
Defective Device 174 174

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 41265 41265
No Known Impact Or Consequence To Patient 22647 22650
No Consequences Or Impact To Patient 20662 20666
Hyperglycemia 17319 17320
No Information 6482 6483
Hypoglycemia 3383 3383
Diabetic Ketoacidosis 738 738
Low Blood Pressure/ Hypotension 587 587
Death 521 522
Nausea 423 423
Vomiting 370 370
Underdose 336 336
Aneurysm 295 295
Overdose 293 293
Not Applicable 257 257
No Code Available 254 254
Loss of consciousness 182 182
Blood Loss 171 171
Abdominal Pain 152 152
Therapeutic Response, Increased 150 150
High Blood Pressure/ Hypertension 146 146
Pain 138 138
Dyspnea 135 135
No Clinical Signs, Symptoms or Conditions 135 135
Headache 114 114
Cardiac Arrest 92 92
Therapeutic Response, Decreased 84 84
Complaint, Ill-Defined 83 83
Bradycardia 79 79
Seizures 64 64
Tachycardia 57 57
Dizziness 57 57
Polydipsia 50 50
Coma 50 50
Fatigue 50 50
Unspecified Infection 45 45
Injury 44 44
Cardiopulmonary Arrest 43 43
Oversedation 43 43
Therapeutic Effects, Unexpected 42 42
Missed Dose 42 42
Respiratory Distress 40 40
Low Oxygen Saturation 39 39
Infiltration into Tissue 38 38
Chest Pain 38 38
Patient Problem/Medical Problem 38 38
Chemical Exposure 37 37
Venipuncture 37 37
Skin Irritation 37 37
Lethargy 33 33
Discomfort 32 32
Diarrhea 32 32
Weakness 30 30
Shaking/Tremors 28 28
Dehydration 27 27
Sweating 26 26
Urinary Frequency 26 26
Arrhythmia 25 25
Confusion/ Disorientation 23 23
Inadequate Pain Relief 23 23
Anxiety 23 23
Swelling 23 23
Rash 21 21
Decreased Respiratory Rate 20 20
Hypoxia 20 20
Hemorrhage/Bleeding 19 19
Erythema 18 18
Apnea 17 17
Burning Sensation 17 17
Blurred Vision 17 17
Bruise/Contusion 16 16
Itching Sensation 16 16
Electric Shock 15 15
Loss Of Pulse 15 15
Fetal Distress 15 15
Irritation 15 15
Sedation 15 15
Palpitations 14 14
Toxicity 12 12
Cognitive Changes 12 12
Renal Failure 12 12
Test Result 11 11
Electrolyte Imbalance 11 11
Hot Flashes/Flushes 10 10
Fall 10 10
Fever 10 10
Extravasation 10 10
Ventricular Tachycardia 10 10
Reaction, Injection Site 9 9
Inflammation 9 9
Hypoventilation 9 9
Distress 9 9
Premature Labor 9 9
Chest Tightness/Pressure 8 8
Alteration In Body Temperature 8 8
Missing Value Reason 8 8
Reaction 8 8
Myocardial Infarction 8 8
Atrial Fibrillation 8 8
Coagulation Disorder 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-25-2015
2 Baxter Healthcare Corp II Apr-16-2015
3 Baxter Healthcare Corp. II Nov-29-2016
4 Baxter Healthcare Corporation II May-02-2019
5 Baxter Healthcare Corporation II Jun-07-2018
6 Baxter Healthcare Corporation II May-04-2018
7 Baxter Healthcare Corporation II Mar-12-2018
8 Baxter Healthcare Corporation II Oct-02-2017
9 Bayer Healthcare II Feb-08-2017
10 Bayer Healthcare II Nov-11-2016
11 Bayer Healthcare II Jan-11-2016
12 CME America, LLC I Mar-18-2020
13 CME America, LLC I Mar-11-2020
14 CME America, LLC II Feb-19-2015
15 CareFusion 303, Inc. I Sep-12-2020
16 CareFusion 303, Inc. I Sep-04-2020
17 CareFusion 303, Inc. I Sep-04-2020
18 CareFusion 303, Inc. II Aug-19-2020
19 CareFusion 303, Inc. I Aug-06-2020
20 CareFusion 303, Inc. I Aug-06-2020
21 CareFusion 303, Inc. I Aug-06-2020
22 CareFusion 303, Inc. I Mar-05-2020
23 CareFusion 303, Inc. I Jul-16-2019
24 CareFusion 303, Inc. II Jan-08-2018
25 CareFusion 303, Inc. II Oct-19-2017
26 CareFusion 303, Inc. II Jun-19-2017
27 CareFusion 303, Inc. II Jun-19-2017
28 CareFusion 303, Inc. II Mar-21-2017
29 CareFusion 303, Inc. I Jan-18-2017
30 CareFusion 303, Inc. II Sep-23-2016
31 CareFusion 303, Inc. II Jun-28-2016
32 CareFusion 303, Inc. II May-04-2016
33 CareFusion 303, Inc. I Aug-14-2015
34 CareFusion 303, Inc. II Jun-16-2015
35 CareFusion 303, Inc. II Mar-23-2015
36 CareFusion Corporation II Jun-26-2015
37 Elite Biomedical Solutions LLC I Aug-20-2015
38 Fenwal Inc I Aug-12-2019
39 Fresenius Vial Sa II Nov-02-2018
40 Hospira Inc. II Nov-04-2016
41 Hospira Inc. II Nov-03-2016
42 Hospira Inc. II Oct-24-2016
43 Hospira Inc. II Sep-06-2016
44 Hospira Inc. II Jul-08-2016
45 Hospira Inc. II Jun-27-2016
46 Hospira Inc. II Jun-03-2016
47 Hospira Inc. II Feb-23-2016
48 Hospira Inc. I Feb-23-2015
49 Hospira Inc. II Feb-04-2015
50 Hospira Inc., A Pfizer Company II Mar-24-2017
51 Hospira Inc., A Pfizer Company II Sep-13-2016
52 ICU II Jul-07-2017
53 ICU Medical Inc II Oct-22-2019
54 ICU Medical Inc II Oct-14-2019
55 ICU Medical Inc II Dec-06-2017
56 ICU Medical Inc II Nov-16-2017
57 ICU Medical Inc II Aug-14-2017
58 InfuTronix LLC II Jul-23-2019
59 MOOG Medical Devices Group II Feb-11-2016
60 Medtronic MiniMed Inc. II Jul-24-2015
61 Repro-Med Systems, Inc. II Jan-05-2018
62 Smiths Medical ASD Inc. I Aug-06-2020
63 Smiths Medical ASD Inc. I Dec-12-2019
64 Smiths Medical ASD Inc. II Aug-08-2018
65 Smiths Medical ASD Inc. II Mar-05-2018
66 Smiths Medical ASD Inc. II Jan-04-2018
67 Smiths Medical ASD Inc. II Jan-02-2018
68 Smiths Medical ASD Inc. II Nov-01-2017
69 Smiths Medical ASD Inc. II Aug-25-2017
70 WalkMed Infusion, LLC II Jul-18-2016
71 WalkMed Infusion, LLC II Nov-06-2015
72 WalkMed, LLC II Nov-13-2017
73 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019
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