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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device beta 2-microglobulin apheresis column
Definition Relief of symptoms of clinically diagnosed dialysis-related amyloidosis (DRA).
Product CodePDI
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2021 2 2
2022 1 1
2023 1 1
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Patient-Device Incompatibility 4 4
Patient Device Interaction Problem 4 4
Decrease in Pressure 2 2
Lack of Effect 2 2
No Apparent Adverse Event 2 2
Device Appears to Trigger Rejection 2 2
Biocompatibility 2 2
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Blood Pressure/ Hypotension 11 11
Ischemia 4 4
Chest Pain 3 3
High Blood Pressure/ Hypertension 2 2
Urticaria 2 2
Fatigue 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Dizziness 2 2
Anemia 2 2
Itching Sensation 2 2
Anaphylactoid 2 2
Transient Ischemic Attack 2 2
Erythema 2 2
Vertigo 2 2
Vomiting 2 2
Insufficient Information 2 2
Visual Impairment 2 2
Blurred Vision 2 2
Headache 2 2
Loss of consciousness 2 2
Ambulation Difficulties 2 2
Syncope/Fainting 1 1
Presyncope 1 1
Fever 1 1
Chills 1 1
Tachycardia 1 1
Low Oxygen Saturation 1 1

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