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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 2
DEKA RESEARCH & DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
IVENIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q CORE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
REPRO-MED SYSTEMS, INC., DBA KORU MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
REPRO-MED SYSTEMS, INC., DBA RMS MEDICAL PRODUCTS
  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
2017 12059 12059
2018 16585 16585
2019 15857 15857
2020 94219 94219
2021 199381 199381
2022 506760 506760

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 474118 474118
Corroded 92481 92481
Break 65554 65554
Display Difficult to Read 32901 32901
Device Sensing Problem 32786 32786
Failure to Read Input Signal 25809 25809
Contamination 21798 21798
Device Alarm System 18828 18828
No Apparent Adverse Event 18612 18612
Display or Visual Feedback Problem 16893 16893
Appropriate Term/Code Not Available 16101 16101
Electrical /Electronic Property Problem 13142 13142
Battery Problem 9582 9582
Insufficient Information 9240 9240
Circuit Failure 9229 9229
Failure to Calibrate 8770 8770
Device Displays Incorrect Message 8558 8558
Computer Software Problem 8416 8416
Excess Flow or Over-Infusion 7256 7256
Insufficient Flow or Under Infusion 6879 6879
Misassembled 6849 6849
False Alarm 6397 6397
Physical Resistance/Sticking 6175 6175
No Display/Image 4867 4867
Deformation Due to Compressive Stress 4814 4814
Mechanics Altered 4776 4776
Premature Discharge of Battery 4482 4482
Communication or Transmission Problem 4241 4241
Failure to Align 3666 3666
Peeled/Delaminated 3445 3445
Failure to Power Up 3390 3390
Naturally Worn 3271 3271
Protective Measures Problem 3259 3259
Improper Flow or Infusion 3216 3216
Fluid Leak 2903 2903
Output Problem 2811 2811
Application Program Freezes, Becomes Nonfunctional 2476 2476
Failure to Sense 2410 2410
Adverse Event Without Identified Device or Use Problem 2392 2392
Defective Alarm 2373 2373
Infusion or Flow Problem 2351 2351
Charging Problem 2096 2096
Inaccurate Delivery 2067 2067
Air Leak 2010 2010
Device Operates Differently Than Expected 1982 1982
Pumping Stopped 1728 1728
Positioning Problem 1474 1474
Obstruction of Flow 1461 1461
Loose or Intermittent Connection 1430 1430
Audible Prompt/Feedback Problem 1400 1400
Material Discolored 1270 1270
Calibration Problem 1237 1237
Application Program Problem 1224 1224
Mechanical Problem 1135 1135
Failure to Deliver 1095 1095
Degraded 1013 1013
Pressure Problem 988 988
Leak/Splash 929 929
Filling Problem 903 903
Volume Accuracy Problem 896 896
No Audible Prompt/Feedback 884 884
Failure to Cycle 761 761
Failure to Analyze Signal 698 698
Device Markings/Labelling Problem 681 681
Difficult or Delayed Activation 669 669
Inaccurate Flow Rate 641 641
Complete Loss of Power 621 621
Defective Component 555 555
Application Program Version or Upgrade Problem 553 553
Fracture 551 551
Unexpected Shutdown 521 521
Use of Device Problem 505 505
No Audible Alarm 498 498
Occlusion Within Device 434 434
Material Rupture 424 424
Power Problem 422 422
Free or Unrestricted Flow 412 412
Inaccurate Information 409 409
Noise, Audible 388 388
Patient Device Interaction Problem 374 374
Bent 349 349
Improper or Incorrect Procedure or Method 344 344
Connection Problem 337 337
Wireless Communication Problem 301 301
Inaudible or Unclear Audible Prompt/Feedback 275 275
Failure to Infuse 271 271
Missing Information 265 265
Device Difficult to Setup or Prepare 251 251
Thermal Decomposition of Device 247 247
Nonstandard Device 237 237
No Flow 214 214
High Test Results 203 203
Computer Operating System Problem 203 203
Defective Device 198 198
Material Fragmentation 195 195
Intermittent Loss of Power 194 194
Therapeutic or Diagnostic Output Failure 173 173
Device Contamination with Chemical or Other Material 171 171
Device Inoperable 170 170
Failure to Charge 168 168

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 417079 417079
No Clinical Signs, Symptoms or Conditions 265039 265039
No Patient Involvement 120136 120138
No Consequences Or Impact To Patient 19665 19675
Hyperglycemia 10308 10308
No Known Impact Or Consequence To Patient 8252 8254
No Information 7850 7852
Hypoglycemia 3769 3769
Low Blood Pressure/ Hypotension 651 651
Diabetic Ketoacidosis 646 646
Nausea 425 425
Death 417 418
Vomiting 326 326
Not Applicable 249 249
Loss of consciousness 207 207
High Blood Pressure/ Hypertension 181 181
Overdose 173 173
No Code Available 164 164
Blood Loss 163 163
Abdominal Pain 156 156
Dyspnea 152 152
Pain 143 143
Cardiac Arrest 127 127
Headache 122 122
Therapeutic Response, Increased 114 114
Underdose 101 101
Bradycardia 93 93
Fatigue 81 81
Tachycardia 73 73
Complaint, Ill-Defined 67 67
Dizziness 67 67
Seizures 60 60
Shaking/Tremors 59 59
Therapeutic Response, Decreased 56 56
Coma 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Anxiety 48 48
Oversedation 47 47
Cardiopulmonary Arrest 46 46
Discomfort 43 43
Low Oxygen Saturation 43 43
Chest Pain 42 42
Therapeutic Effects, Unexpected 39 39
Confusion/ Disorientation 38 38
Polydipsia 36 36
Injury 34 34
Missed Dose 32 32
Skin Irritation 31 31
Unspecified Infection 31 31
Diarrhea 31 31
Arrhythmia 31 32
Hypoxia 29 29
Chemical Exposure 29 29
Premature Labor 29 29
Patient Problem/Medical Problem 29 29
Weakness 29 29
Respiratory Distress 28 29
Venipuncture 26 26
Lethargy 26 26
Infiltration into Tissue 24 24
Coagulation Disorder 24 24
Fetal Distress 22 22
Sweating 22 22
Rash 21 21
Itching Sensation 19 19
Erythema 19 19
Bruise/Contusion 19 19
Decreased Respiratory Rate 19 19
Blurred Vision 18 18
Hot Flashes/Flushes 17 17
Dehydration 17 17
Swelling 16 16
Burning Sensation 16 16
Sedation 16 16
Apnea 15 15
Awareness during Anaesthesia 15 15
Urethral Stenosis/Stricture 15 15
Hemorrhage/Bleeding 14 14
Inadequate Pain Relief 14 14
Diaphoresis 14 14
Malaise 13 13
Muscle Weakness 13 13
Irritation 12 12
Fever 12 12
Urinary Frequency 12 12
Electrolyte Imbalance 12 12
Loss Of Pulse 12 12
Increased Respiratory Rate 11 11
Toxicity 11 11
Distress 10 10
Respiratory Failure 10 10
Cognitive Changes 10 10
Hematoma 10 10
Intracranial Hemorrhage 10 10
Skin Discoloration 10 10
Hypersensitivity/Allergic reaction 9 9
Extravasation 9 9
Palpitations 9 9
Irritability 9 9
Reaction, Injection Site 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 Baxter Healthcare Corporation II Oct-02-2017
13 Bayer Healthcare II Feb-08-2017
14 BioMedical Equipment Service Co (BMES) I Aug-06-2021
15 CME America LLC II Oct-29-2020
16 CME America, LLC II Dec-03-2020
17 CME America, LLC I Mar-18-2020
18 CME America, LLC I Mar-11-2020
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 CareFusion 303, Inc. II Oct-19-2017
31 CareFusion 303, Inc. II Jun-19-2017
32 CareFusion 303, Inc. II Jun-19-2017
33 CareFusion 303, Inc. II Mar-21-2017
34 CareFusion 303, Inc. I Jan-18-2017
35 Fenwal Inc I Aug-12-2019
36 Fresenius Vial Sa II Nov-02-2018
37 Hospira Inc., A Pfizer Company II Mar-24-2017
38 ICU II Jul-07-2017
39 ICU Medical Inc II Oct-22-2019
40 ICU Medical Inc II Oct-14-2019
41 ICU Medical Inc II Dec-06-2017
42 ICU Medical Inc II Nov-16-2017
43 ICU Medical Inc II Aug-14-2017
44 InfuTronix LLC II Mar-29-2022
45 InfuTronix LLC II Jul-23-2019
46 Infusion Pump Repair I May-10-2021
47 Pacific Medical Group Inc. I Apr-19-2021
48 Repro-Med Systems, Inc. II Jan-05-2018
49 STEP-HAR MEDICAL LLC I May-10-2021
50 Smiths Medical ASD Inc. II Feb-17-2022
51 Smiths Medical ASD Inc. I Oct-19-2021
52 Smiths Medical ASD Inc. I Aug-06-2020
53 Smiths Medical ASD Inc. I Dec-12-2019
54 Smiths Medical ASD Inc. II Aug-08-2018
55 Smiths Medical ASD Inc. II Mar-05-2018
56 Smiths Medical ASD Inc. II Jan-04-2018
57 Smiths Medical ASD Inc. II Jan-02-2018
58 Smiths Medical ASD Inc. II Nov-01-2017
59 Smiths Medical ASD Inc. II Aug-25-2017
60 Tenacore LLC I Apr-02-2021
61 The Biomed Guys I Jun-01-2021
62 WalkMed, LLC II Nov-13-2017
63 Zevex Incorporated (dba MOOG Medical Devices Group) II Jul-23-2019
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