• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH & DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IVENIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q CORE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
REPRO-MED SYSTEMS, INC., DBA RMS MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 16557 16557
2017 12059 12059
2018 16584 16584
2019 15857 15857
2020 94219 94219
2021 64221 64221

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 34816 34816
Break 24198 24198
Corroded 17899 17899
No Apparent Adverse Event 17379 17379
Device Displays Incorrect Message 16720 16720
Display or Visual Feedback Problem 16630 16630
Appropriate Term/Code Not Available 16087 16087
Device Alarm System 14815 14815
Device Sensing Problem 13802 13802
Electrical /Electronic Property Problem 12598 12598
Failure to Read Input Signal 9059 9059
Display Difficult to Read 8936 8936
Contamination 8309 8309
Computer Software Problem 8241 8241
Insufficient Information 7274 7274
Circuit Failure 7237 7237
Excess Flow or Over-Infusion 7029 7029
Insufficient Flow or Under Infusion 6445 6445
False Alarm 5616 5616
Physical Resistance/Sticking 5026 5026
Misassembled 4858 4858
Mechanics Altered 4672 4672
Deformation Due to Compressive Stress 4579 4579
Air Leak 3846 3846
Failure to Power Up 3212 3212
Device Operates Differently Than Expected 3073 3073
Improper Flow or Infusion 3039 3039
Fluid Leak 2907 2907
Naturally Worn 2527 2527
Adverse Event Without Identified Device or Use Problem 2504 2504
Communication or Transmission Problem 2375 2375
Infusion or Flow Problem 2304 2304
Failure to Deliver 2292 2292
Defective Alarm 2255 2255
Protective Measures Problem 2112 2112
Failure to Calibrate 1949 1949
Output Problem 1838 1838
No Display/Image 1779 1779
Pumping Stopped 1760 1760
Battery Problem 1596 1596
Failure to Sense 1554 1554
Leak/Splash 1390 1390
Charging Problem 1370 1370
Application Program Freezes, Becomes Nonfunctional 1368 1368
Obstruction of Flow 1299 1299
Material Discolored 1273 1273
Inaccurate Delivery 1251 1251
Occlusion Within Device 1212 1212
Degraded 997 997
Premature Discharge of Battery 989 989
Peeled/Delaminated 960 960
Pressure Problem 959 959
Mechanical Problem 867 867
Calibration Problem 854 854
Failure to Cycle 760 760
Audible Prompt/Feedback Problem 694 694
Volume Accuracy Problem 681 681
No Audible Prompt/Feedback 657 657
Inaccurate Flow Rate 626 626
Difficult or Delayed Activation 610 610
Failure to Align 604 604
Filling Problem 596 596
Loose or Intermittent Connection 593 593
Application Program Version or Upgrade Problem 551 551
Complete Loss of Power 530 530
Failure to Analyze Signal 529 529
Free or Unrestricted Flow 524 524
Bent 510 510
No Audible Alarm 504 504
Material Rupture 493 493
Defective Component 490 490
Use of Device Problem 452 452
Nonstandard Device 451 451
Unexpected Shutdown 442 442
Improper or Incorrect Procedure or Method 429 429
Power Problem 389 389
No Flow 386 386
Noise, Audible 373 373
Patient Device Interaction Problem 368 368
Device Inoperable 360 360
Connection Problem 349 349
Device Markings/Labelling Problem 310 310
Wireless Communication Problem 295 295
Failure to Prime 284 284
High Test Results 277 277
Failure to Infuse 263 263
Thermal Decomposition of Device 250 250
Application Program Problem 247 247
Device Difficult to Setup or Prepare 246 246
Loss of Power 241 241
Disconnection 218 218
Material Fragmentation 198 198
Defective Device 186 186
Device Contamination with Chemical or Other Material 184 184
Intermittent Loss of Power 177 177
Failure to Charge 167 167
Material Integrity Problem 158 158
Computer Operating System Problem 157 157
Material Separation 154 154
Component Missing 152 152

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 124095 124097
No Clinical Signs, Symptoms or Conditions 38420 38420
No Consequences Or Impact To Patient 21345 21355
Hyperglycemia 14682 14683
No Known Impact Or Consequence To Patient 13765 13767
No Information 8080 8082
Hypoglycemia 3768 3768
Insufficient Information 2504 2504
Diabetic Ketoacidosis 755 755
Low Blood Pressure/ Hypotension 644 644
Death 506 507
Nausea 442 442
Vomiting 373 373
Not Applicable 252 252
Overdose 229 229
No Code Available 213 213
Loss of consciousness 200 200
High Blood Pressure/ Hypertension 181 181
Blood Loss 167 167
Abdominal Pain 161 161
Pain 148 148
Dyspnea 146 146
Therapeutic Response, Increased 140 140
Underdose 137 137
Headache 124 124
Cardiac Arrest 118 118
Bradycardia 92 92
Therapeutic Response, Decreased 75 75
Complaint, Ill-Defined 73 73
Fatigue 72 72
Tachycardia 65 65
Seizures 63 63
Dizziness 62 62
Coma 54 54
Oversedation 52 52
Cardiopulmonary Arrest 49 49
Polydipsia 48 48
Missed Dose 47 47
Therapeutic Effects, Unexpected 45 45
Shaking/Tremors 45 45
Patient Problem/Medical Problem 42 42
Unspecified Infection 41 41
Chest Pain 41 41
Low Oxygen Saturation 40 40
Injury 39 39
Anxiety 39 39
Discomfort 37 37
Chemical Exposure 36 36
Lethargy 35 35
Skin Irritation 35 35
Confusion/ Disorientation 34 34
Weakness 34 34
Hypoxia 34 34
Respiratory Distress 33 34
Venipuncture 33 33
Diarrhea 31 31
Infiltration into Tissue 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Premature Labor 29 29
Arrhythmia 28 29
Sweating 26 26
Coagulation Disorder 23 23
Rash 22 22
Swelling 21 21
Dehydration 21 21
Fetal Distress 20 20
Decreased Respiratory Rate 20 20
Urinary Frequency 19 19
Bruise/Contusion 19 19
Blurred Vision 19 19
Itching Sensation 18 18
Hemorrhage/Bleeding 18 18
Apnea 18 18
Erythema 18 18
Burning Sensation 17 17
Inadequate Pain Relief 17 17
Hot Flashes/Flushes 16 16
Loss Of Pulse 16 16
Sedation 16 16
Diaphoresis 14 14
Respiratory Failure 13 13
Fever 13 13
Awareness during Anaesthesia 13 13
Irritation 12 12
Palpitations 12 12
Toxicity 12 12
Malaise 12 12
Cognitive Changes 12 12
Electrolyte Imbalance 12 12
Hematoma 11 11
Intracranial Hemorrhage 10 10
Fall 10 10
Ventricular Tachycardia 10 10
Distress 10 10
Increased Respiratory Rate 9 9
Reaction, Injection Site 9 9
Inflammation 9 9
Hypoventilation 9 9
Renal Failure 9 9
Extravasation 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Nov-29-2016
2 Baxter Healthcare Corporation I Aug-11-2021
3 Baxter Healthcare Corporation I Aug-06-2021
4 Baxter Healthcare Corporation II Apr-23-2021
5 Baxter Healthcare Corporation II Feb-25-2021
6 Baxter Healthcare Corporation II Dec-23-2020
7 Baxter Healthcare Corporation I Oct-22-2020
8 Baxter Healthcare Corporation II May-02-2019
9 Baxter Healthcare Corporation II Jun-07-2018
10 Baxter Healthcare Corporation II May-04-2018
11 Baxter Healthcare Corporation II Mar-12-2018
12 Baxter Healthcare Corporation II Oct-02-2017
13 Bayer Healthcare II Feb-08-2017
14 Bayer Healthcare II Nov-11-2016
15 Bayer Healthcare II Jan-11-2016
16 BioMedical Equipment Service Co (BMES) I Aug-06-2021
17 CME America LLC II Oct-29-2020
18 CME America, LLC II Dec-03-2020
19 CME America, LLC I Mar-18-2020
20 CME America, LLC I Mar-11-2020
21 CareFusion 303, Inc. I Apr-01-2021
22 CareFusion 303, Inc. I Sep-12-2020
23 CareFusion 303, Inc. I Sep-04-2020
24 CareFusion 303, Inc. I Sep-04-2020
25 CareFusion 303, Inc. II Aug-19-2020
26 CareFusion 303, Inc. I Aug-06-2020
27 CareFusion 303, Inc. I Aug-06-2020
28 CareFusion 303, Inc. I Aug-06-2020
29 CareFusion 303, Inc. I Mar-05-2020
30 CareFusion 303, Inc. I Jul-16-2019
31 CareFusion 303, Inc. II Jan-08-2018
32 CareFusion 303, Inc. II Oct-19-2017
33 CareFusion 303, Inc. II Jun-19-2017
34 CareFusion 303, Inc. II Jun-19-2017
35 CareFusion 303, Inc. II Mar-21-2017
36 CareFusion 303, Inc. I Jan-18-2017
37 CareFusion 303, Inc. II Sep-23-2016
38 CareFusion 303, Inc. II Jun-28-2016
39 CareFusion 303, Inc. II May-04-2016
40 Fenwal Inc I Aug-12-2019
41 Fresenius Vial Sa II Nov-02-2018
42 Hospira Inc. II Nov-04-2016
43 Hospira Inc. II Nov-03-2016
44 Hospira Inc. II Oct-24-2016
45 Hospira Inc. II Sep-06-2016
46 Hospira Inc. II Jul-08-2016
47 Hospira Inc. II Jun-27-2016
48 Hospira Inc. II Jun-03-2016
49 Hospira Inc. II Feb-23-2016
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 Infusion Pump Repair I May-10-2021
60 MOOG Medical Devices Group II Feb-11-2016
61 Pacific Medical Group Inc. I Apr-19-2021
62 Repro-Med Systems, Inc. II Jan-05-2018
63 STEP-HAR MEDICAL LLC I May-10-2021
64 Smiths Medical ASD Inc. I Aug-06-2020
65 Smiths Medical ASD Inc. I Dec-12-2019
66 Smiths Medical ASD Inc. II Aug-08-2018
67 Smiths Medical ASD Inc. II Mar-05-2018
68 Smiths Medical ASD Inc. II Jan-04-2018
69 Smiths Medical ASD Inc. II Jan-02-2018
70 Smiths Medical ASD Inc. II Nov-01-2017
71 Smiths Medical ASD Inc. II Aug-25-2017
72 Tenacore LLC I Apr-02-2021
73 The Biomed Guys I Jun-01-2021
74 WalkMed Infusion, LLC II Jul-18-2016
75 WalkMed, LLC II Nov-13-2017
76 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019
-
-