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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
2016 2 2
2018 4 4
2019 2 2
2020 1 1
2021 2 2
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
No Apparent Adverse Event 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 10 10
Tachycardia 4 4
Fever 3 3
Hypovolemic Shock 2 2
Arrhythmia 2 2
Chest Pain 2 2
Dyspnea 2 2
Chills 2 2
Loss of consciousness 2 2
Low Oxygen Saturation 2 2
Presyncope 1 1
Syncope/Fainting 1 1
Hypovolemia 1 1
Discomfort 1 1
Vomiting 1 1
Fatigue 1 1
Respiratory Distress 1 1
Hemolysis 1 1
High Blood Pressure/ Hypertension 1 1
Abdominal Pain 1 1

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