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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pump, infusion, elastomeric
Product CodeMEB
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
ACE MEDICAL US, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC MEDICAL PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
HALYARD HEALTH
  SUBSTANTIALLY EQUIVALENT 1
I-FLOW LLC
  SUBSTANTIALLY EQUIVALENT 1
MFS - MEDICAL FLOW SYSTEMS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2695 2695
2015 2979 2979
2016 2146 2146
2017 1653 1653
2018 1473 1564
2019 974 4421
2020 2731 3223
2021 1802 1802
2022 1288 1288
2023 1249 1249
2024 430 430

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 4342 7058
Filling Problem 3776 4288
Material Rupture 1938 2259
No Flow 1871 2146
Device Contamination with Chemical or Other Material 1747 1896
Infusion or Flow Problem 1056 1056
Excess Flow or Over-Infusion 966 966
Leak/Splash 635 635
Inaccurate Flow Rate 632 632
Failure to Infuse 461 461
Break 403 425
Adverse Event Without Identified Device or Use Problem 267 267
Disconnection 258 258
Insufficient Flow or Under Infusion 243 243
Failure to Deliver 146 146
Device Operates Differently Than Expected 143 143
Detachment Of Device Component 142 142
Component Missing 135 138
Crack 95 99
Improper Flow or Infusion 89 89
Loose or Intermittent Connection 87 88
Contamination /Decontamination Problem 45 45
Failure to Prime 44 44
Material Separation 40 40
Detachment of Device or Device Component 39 40
Material Deformation 35 36
Reflux within Device 34 34
Improper or Incorrect Procedure or Method 32 32
Burst Container or Vessel 29 29
Particulates 25 25
Material Split, Cut or Torn 25 26
Backflow 19 19
Material Twisted/Bent 15 15
Insufficient Information 14 14
Physical Resistance/Sticking 14 14
Material Integrity Problem 13 13
Split 13 13
Defective Device 13 13
Material Puncture/Hole 12 15
Sticking 11 11
Deflation Problem 11 11
Connection Problem 11 11
Inaccurate Delivery 11 11
Pumping Problem 11 11
Scratched Material 11 11
Appropriate Term/Code Not Available 11 11
Chemical Spillage 10 10
Fracture 9 9
Product Quality Problem 9 9
Application Program Problem: Medication Error 9 9
Torn Material 8 8
Partial Blockage 8 8
Cut In Material 8 8
Defective Component 8 8
Obstruction of Flow 7 7
Device Contaminated During Manufacture or Shipping 7 7
Misconnection 7 7
Use of Device Problem 7 7
Device Damaged Prior to Use 6 6
Overfill 5 5
Patient-Device Incompatibility 5 5
Device Dislodged or Dislocated 5 5
Material Fragmentation 5 5
Hole In Material 5 5
Air/Gas in Device 5 5
Mechanical Problem 4 4
Inadequate Instructions for Healthcare Professional 4 4
Device Alarm System 4 4
Bent 4 4
Stretched 4 4
Short Fill 4 4
Free or Unrestricted Flow 4 4
Device Markings/Labelling Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Displays Incorrect Message 4 4
Malposition of Device 4 4
Device Operational Issue 3 3
Device Packaging Compromised 3 3
Difficult to Open or Close 3 3
Fitting Problem 3 26
Material Perforation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Packaging Problem 3 3
Positioning Problem 3 3
Environmental Particulates 3 3
Volume Accuracy Problem 3 3
Device Slipped 3 3
Device Inoperable 3 3
Retraction Problem 3 3
Precipitate in Device or Device Ingredient 3 3
Device Difficult to Setup or Prepare 3 3
Failure to Pump 3 3
Degraded 3 3
Material Discolored 3 3
Melted 3 3
Priming Problem 3 3
Noise, Audible 3 3
Activation Problem 2 2
Migration or Expulsion of Device 2 2
Kinked 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6982 9090
No Clinical Signs, Symptoms or Conditions 4203 4203
No Consequences Or Impact To Patient 4003 4879
No Known Impact Or Consequence To Patient 2547 3597
No Information 498 498
Insufficient Information 146 146
Pain 125 125
Underdose 113 113
Nausea 106 106
No Code Available 95 95
Overdose 80 80
Numbness 62 62
Reaction 45 45
Tinnitus 44 44
Vomiting 42 42
Unspecified Infection 41 41
Fatigue 38 38
Foreign Body In Patient 37 37
Toxicity 33 33
Chemical Exposure 31 31
Discomfort 30 30
Fever 30 30
Dizziness 29 29
Diarrhea 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
Device Embedded In Tissue or Plaque 24 24
Malaise 24 24
Injury 20 20
Rash 20 20
Death 20 20
Tachycardia 19 19
Swelling 18 18
Chest Pain 17 17
Itching Sensation 17 17
Dyspnea 16 16
Abdominal Pain 15 15
Inadequate Pain Relief 15 15
Blurred Vision 14 14
High Blood Pressure/ Hypertension 14 14
Headache 13 13
Chills 13 13
Confusion/ Disorientation 13 13
Missed Dose 11 11
Hot Flashes/Flushes 11 11
Low Blood Pressure/ Hypotension 11 11
Muscle Weakness 10 10
Respiratory Distress 10 10
Post Operative Wound Infection 10 10
Anxiety 10 10
Lethargy 10 10
Taste Disorder 9 9
Seizures 9 9
Weakness 9 9
Inflammation 9 9
Nerve Damage 8 8
Shaking/Tremors 8 8
Palpitations 7 7
Dysphagia/ Odynophagia 7 7
Cardiac Arrest 7 7
Diaphoresis 7 7
Tingling 6 6
Bacterial Infection 6 6
Sweating 6 6
Thromboembolism 5 5
Swelling/ Edema 5 5
Pulmonary Embolism 5 5
Dehydration 5 5
Necrosis 5 5
Jaundice 5 5
Burning Sensation 5 5
Skin Irritation 5 5
Neuropathy 4 4
Ulcer 4 4
Hyperthermia 4 4
Edema 4 4
Sleep Dysfunction 4 4
Abdominal Cramps 3 3
Vascular System (Circulation), Impaired 3 3
Decreased Sensitivity 3 3
Patient Problem/Medical Problem 3 3
Partial thickness (Second Degree) Burn 3 3
Test Result 3 3
Unspecified Kidney or Urinary Problem 3 3
Erythema 3 3
Fall 3 3
Cellulitis 3 3
Purulent Discharge 3 3
Arrhythmia 3 3
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Incontinence 3 3
Muscle Spasm(s) 3 3
Peeling 3 3
Pneumonia 3 3
Distress 3 3
Arthralgia 3 3
Complaint, Ill-Defined 3 3
Sprain 3 3
Skin Discoloration 3 3
Sepsis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Feb-25-2019
2 B. Braun Medical, Inc. II Sep-16-2014
3 B. Braun Medical, Inc. II Feb-03-2014
4 Baxter Healthcare Corp. II Jul-10-2013
5 Baxter Healthcare Corp. II Jun-27-2013
6 Baxter Healthcare Corp. II Jun-27-2013
7 Baxter Healthcare Corp. II May-05-2011
8 First Medical Source LLC I Oct-30-2012
9 Hsmg, Inc. D/b/a Smartinfuser Usa II Apr-14-2011
10 Hsmg, Inc. D/b/a Smartinfuser Usa II Mar-08-2010
11 I-Flow Corporation I Aug-28-2012
12 I-Flow Corporation II Jul-28-2011
13 I-Flow Corporation II Sep-14-2009
14 Leventon S. A. U. II Aug-23-2019
15 Progressive Medical Inc I Oct-24-2011
16 Stryker Instruments Div. of Stryker Corporation II Sep-04-2009
17 Symbios Medical Products, LLC I Jun-06-2013
18 Symbios Medical Products, LLC I Mar-13-2013
19 Victus, Inc. I Oct-24-2011
20 Wolf Medical Supply Inc. I Nov-23-2011
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