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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
B.BRAUN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
DEKA RESEARCH & DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
EITAN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
IVENIX, INC.
  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
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 16587 16587
2019 15857 15857
2020 94219 94219
2021 199379 199379
2022 888084 888084
2023 26180 26180

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 715915 715915
Corroded 146321 146321
Break 92461 92461
Display Difficult to Read 63003 63003
Failure to Read Input Signal 43498 43498
Device Sensing Problem 42349 42349
Contamination 25857 25857
Device Alarm System 25456 25456
No Apparent Adverse Event 20332 20332
Display or Visual Feedback Problem 17247 17247
Appropriate Term/Code Not Available 16171 16171
Physical Resistance/Sticking 13801 13801
Electrical /Electronic Property Problem 13516 13516
Battery Problem 13063 13063
Failure to Calibrate 12989 12989
Insufficient Information 12240 12240
Circuit Failure 11677 11677
No Display/Image 9112 9112
Premature Discharge of Battery 9016 9016
Computer Software Problem 8522 8522
Failure to Align 8427 8427
Excess Flow or Over-Infusion 7515 7515
Insufficient Flow or Under Infusion 7452 7452
False Alarm 7410 7410
Misassembled 7229 7229
Deformation Due to Compressive Stress 4979 4979
Communication or Transmission Problem 4929 4929
Mechanics Altered 4825 4825
Protective Measures Problem 4710 4710
Application Program Freezes, Becomes Nonfunctional 4164 4164
Naturally Worn 4147 4147
Peeled/Delaminated 3991 3991
Improper Flow or Infusion 3640 3640
Failure to Sense 3587 3587
Failure to Power Up 3452 3452
Device Displays Incorrect Message 3317 3317
Output Problem 3229 3229
Fluid/Blood Leak 2983 2983
Charging Problem 2957 2957
Inaccurate Delivery 2878 2878
Defective Alarm 2803 2803
Obstruction of Flow 2784 2784
Mechanical Problem 2695 2695
Infusion or Flow Problem 2375 2375
Adverse Event Without Identified Device or Use Problem 2280 2280
Audible Prompt/Feedback Problem 2246 2246
Calibration Problem 2195 2195
Positioning Problem 2039 2039
Loose or Intermittent Connection 1829 1829
Pumping Stopped 1816 1816
Application Program Problem 1326 1326
Filling Problem 1299 1299
Material Discolored 1264 1264
Volume Accuracy Problem 1051 1051
Degraded 1018 1018
No Audible Prompt/Feedback 1010 1010
Pressure Problem 1002 1002
Failure to Analyze Signal 919 919
Device Operates Differently Than Expected 873 873
Complete Loss of Power 798 798
Difficult or Delayed Activation 792 792
Failure to Cycle 768 768
Device Markings/Labelling Problem 751 751
Incorrect, Inadequate or Imprecise Result or Readings 715 715
Fracture 689 689
Inaccurate Flow Rate 670 670
Defective Component 644 644
Use of Device Problem 637 637
Connection Problem 632 632
Inaudible or Unclear Audible Prompt/Feedback 604 604
Unexpected Shutdown 604 604
Air/Gas in Device 600 600
Power Problem 568 568
Application Program Version or Upgrade Problem 556 556
No Audible Alarm 530 530
Air Leak 525 525
Leak/Splash 505 505
Misassembly During Maintenance/Repair 503 503
Component Misassembled 491 491
Failure to Deliver 481 481
Inaccurate Information 453 453
Free or Unrestricted Flow 430 430
Noise, Audible 401 401
Patient Device Interaction Problem 398 398
Material Rupture 379 379
Computer Operating System Problem 353 353
Missing Information 334 334
Failure to Infuse 326 326
Wireless Communication Problem 312 312
Improper or Incorrect Procedure or Method 310 310
Thermal Decomposition of Device 294 294
Defective Device 262 262
Device Difficult to Setup or Prepare 252 252
Nonstandard Device 233 233
Intermittent Loss of Power 213 213
Therapeutic or Diagnostic Output Failure 204 204
Material Fragmentation 198 198
Bent 182 182
Material Integrity Problem 180 180
Failure to Charge 177 177

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 647446 647446
No Clinical Signs, Symptoms or Conditions 441370 441370
No Patient Involvement 117654 117656
No Consequences Or Impact To Patient 17583 17593
Hyperglycemia 8258 8258
No Information 7561 7563
No Known Impact Or Consequence To Patient 4453 4453
Hypoglycemia 3838 3838
Low Blood Pressure/ Hypotension 728 728
Diabetic Ketoacidosis 605 605
Nausea 441 441
Death 367 368
Vomiting 320 320
High Blood Pressure/ Hypertension 221 221
Loss of consciousness 209 209
Dyspnea 189 189
Abdominal Pain 168 168
Headache 153 153
Pain 144 144
Blood Loss 143 143
Cardiac Arrest 142 142
Overdose 133 133
No Code Available 118 118
Fatigue 102 102
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 94 94
Bradycardia 90 90
Tachycardia 86 86
Therapeutic Response, Increased 80 80
Dizziness 72 72
Shaking/Tremors 65 65
Coma 57 57
Anxiety 56 56
Seizures 54 54
Confusion/ Disorientation 53 53
Oversedation 47 47
Discomfort 46 46
Underdose 46 46
Chest Pain 45 45
Therapeutic Response, Decreased 43 43
Polydipsia 43 43
Not Applicable 41 41
Low Oxygen Saturation 41 41
Diarrhea 41 41
Therapeutic Effects, Unexpected 33 33
Injury 32 32
Hypoxia 31 31
Lethargy 30 30
Patient Problem/Medical Problem 29 29
Cardiopulmonary Arrest 29 29
Arrhythmia 28 29
Weakness 27 27
Hemorrhage/Bleeding 27 27
Venipuncture 26 26
Premature Labor 26 26
Urethral Stenosis/Stricture 26 26
Unspecified Infection 25 25
Hot Flashes/Flushes 25 25
Coagulation Disorder 24 24
Skin Irritation 23 23
Respiratory Distress 23 24
Muscle Weakness 23 23
Complaint, Ill-Defined 22 22
Malaise 22 22
Missed Dose 22 22
Sweating 21 21
Itching Sensation 20 20
Burning Sensation 20 20
Rash 19 19
Blurred Vision 19 19
Increased Respiratory Rate 18 18
Bruise/Contusion 18 18
Swelling/ Edema 18 18
Erythema 18 18
Infiltration into Tissue 18 18
Fetal Distress 18 18
Awareness during Anaesthesia 17 17
Inadequate Pain Relief 16 16
Hypersensitivity/Allergic reaction 15 15
Diaphoresis 15 15
Distress 15 15
Decreased Respiratory Rate 15 15
Fever 14 14
Balance Problems 13 13
Apnea 13 13
Skin Discoloration 13 13
Swelling 13 13
Irritability 13 13
Urinary Frequency 12 12
Irritation 11 11
Respiratory Failure 11 11
Dehydration 11 11
Toxicity 11 11
Sedation 11 11
Extravasation 11 11
Electrolyte Imbalance 11 11
Convulsion/Seizure 10 10
Asystole 10 10
Syncope/Fainting 10 10
Skin Inflammation/ Irritation 10 10
Convulsion, Clonic 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jan-29-2022
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 Bayer Medical Care, Inc. II Jan-06-2023
13 BioMedical Equipment Service Co (BMES) I Aug-06-2021
14 CME America LLC II Oct-29-2020
15 CME America, LLC II Dec-03-2020
16 CME America, LLC I Mar-18-2020
17 CME America, LLC I Mar-11-2020
18 CareFusion 303, Inc. II Mar-01-2023
19 CareFusion 303, Inc. I Apr-01-2021
20 CareFusion 303, Inc. I Sep-12-2020
21 CareFusion 303, Inc. I Sep-04-2020
22 CareFusion 303, Inc. I Sep-04-2020
23 CareFusion 303, Inc. II Aug-19-2020
24 CareFusion 303, Inc. I Aug-06-2020
25 CareFusion 303, Inc. I Aug-06-2020
26 CareFusion 303, Inc. I Aug-06-2020
27 CareFusion 303, Inc. I Mar-05-2020
28 CareFusion 303, Inc. I Jul-16-2019
29 CareFusion 303, Inc. II Jan-08-2018
30 Fenwal Inc I Aug-12-2019
31 Fresenius Vial Sa II Nov-02-2018
32 ICU Medical Inc II Oct-22-2019
33 ICU Medical Inc II Oct-14-2019
34 InfuTronix LLC II Mar-29-2022
35 InfuTronix LLC II Jul-23-2019
36 Infusion Pump Repair I May-10-2021
37 Iradimed Corporation II Mar-30-2023
38 Pacific Medical Group Inc. I Apr-19-2021
39 Repro-Med Systems, Inc. II Jan-05-2018
40 STEP-HAR MEDICAL LLC I May-10-2021
41 Smiths Medical ASD Inc. II Nov-21-2022
42 Smiths Medical ASD Inc. I Jun-21-2022
43 Smiths Medical ASD Inc. II Feb-17-2022
44 Smiths Medical ASD Inc. I Oct-19-2021
45 Smiths Medical ASD Inc. I Aug-06-2020
46 Smiths Medical ASD Inc. I Dec-12-2019
47 Smiths Medical ASD Inc. II Aug-08-2018
48 Smiths Medical ASD Inc. II Mar-05-2018
49 Smiths Medical ASD Inc. II Jan-04-2018
50 Smiths Medical ASD Inc. II Jan-02-2018
51 Tenacore LLC I Apr-02-2021
52 The Biomed Guys I Jun-01-2021
53 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019
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