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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
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 7 7
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 6 6
Tachycardia 2 2
Fever 2 2
Arrhythmia 1 1
Chest Pain 1 1
Dyspnea 1 1
Vomiting 1 1
Chills 1 1
Loss of consciousness 1 1
Low Oxygen Saturation 1 1
Presyncope 1 1
Syncope/Fainting 1 1

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