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TPLC - Total Product Life Cycle
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Device dialyzer, capillary, hollow fiber
Product CodeFJI
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 632 632
2015 561 561
2016 562 562
2017 182 182
2018 11 11
2019 20 20
2020 16 16
2021 12 12
2022 2 2
2023 51 51
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 1589 1589
Adverse Event Without Identified Device or Use Problem 442 442
Insufficient Information 23 23
Crack 21 21
Material Rupture 15 15
Occlusion Within Device 14 14
Break 8 8
Leak/Splash 8 8
Device Issue 5 5
Device Displays Incorrect Message 4 4
Loose or Intermittent Connection 2 2
Filtration Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Improper Chemical Reaction 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
No Flow 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Hole In Material 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Device Alarm System 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Material Separation 1 1
Use of Device Problem 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1475 1475
Itching Sensation 200 200
Reaction 172 172
No Clinical Signs, Symptoms or Conditions 102 102
Hypersensitivity/Allergic reaction 98 98
Death 50 50
Low Blood Pressure/ Hypotension 30 30
Blood Loss 29 29
Loss of consciousness 28 28
Cardiac Arrest 26 26
Nausea 20 20
Cardiopulmonary Arrest 19 19
Seizures 18 18
Dyspnea 15 15
Vomiting 11 11
Fever 10 10
Syncope 9 9
Anxiety 9 9
High Blood Pressure/ Hypertension 8 8
Hemorrhage/Bleeding 8 8
Myocardial Infarction 7 7
Erythema 6 6
Bradycardia 6 6
No Code Available 6 6
Chest Pain 5 5
Tachycardia 5 5
Dizziness 4 4
Respiratory Distress 4 4
Rash 4 4
Arrhythmia 4 4
Pulmonary Embolism 4 4
Anemia 4 4
Thromboembolism 4 4
Loss Of Pulse 4 4
Hypervolemia 3 3
Shaking/Tremors 3 3
Burning Sensation 3 3
First Use Syndrome 3 3
No Consequences Or Impact To Patient 2 2
Diaphoresis 2 2
Low Oxygen Saturation 2 2
Pain 2 2
Pleural Effusion 2 2
Renal Failure 2 2
Increased Sensitivity 2 2
Sepsis 2 2
Anaphylactic Shock 2 2
Bacterial Infection 2 2
Edema 2 2
Encephalopathy 2 2
Hypoxia 2 2
No Patient Involvement 2 2
Malaise 2 2
Respiratory Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 1 1
Sudden Cardiac Death 1 1
Hematuria 1 1
Alteration In Body Temperature 1 1
Vaso-Vagal Response 1 1
Muscle Hypotonia 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Incontinence 1 1
Unspecified Infection 1 1
Irritation 1 1
Hiccups 1 1
Hypoglycemia 1 1
Fall 1 1
Hair Loss 1 1
Pyrosis/Heartburn 1 1
Hemolysis 1 1
Aspiration/Inhalation 1 1
Diarrhea 1 1
Aneurysm 1 1
Angina 1 1
Abdominal Pain 1 1
Achalasia 1 1
Air Embolism 1 1
Swelling 1 1
Staphylococcus Aureus 1 1
Pulmonary Infarction 1 1
Renal Disease, End Stage 1 1
Lupus 1 1
Respiratory Acidosis 1 1
Anaphylactoid 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Sneezing 1 1
Hot Flashes/Flushes 1 1
Chills 1 1
Electrolyte Imbalance 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Renal Therapies Group, LLC II Apr-05-2016
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