BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 22897646 · Received August 26, 2025

    Report

    Report Number
    3014015528-2025-00025
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    September 18, 2020
    Report Date
    August 25, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT WAS RE-EVALUATED AS PART OF COMPLAINT REMEDIATION ACTIVITIES AND DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2020, PATIENT (MALE, 67 YEARS OLD, DIAGNOSED WITH COVID-19 ARDS) EXPERIENCED AN ACUTE BRADYCARDIC HYPOTENSIVE EVENT DURING HIS FOURTH SERAPH 100 FILTER TREATMENT. TREATMENT WAS STOPPED APPROXIMATELY 2.5HRS INTO A 5H PLANNED TREATMENT WHEN BP DROPPED FROM 131/65 AT START OF TREATMENT TO 28/23 WHEN TREATMENT WAS HALTED AND LIFE SAVING MEASURES WERE INITIATED. HYPOTENSION WAS TREATED WITH ATROPINE AND ACLS AND RESOLVED WITH SEQUALAE THE SAME DAY. PER THE DATA SHEET PROVIDED BY DDEAMC, THE PATIENT'S REPORTED HYPOTENSION WAS ALLEGED TO BE "POSSIBLY RELATED" TO THE DEVICE AS WELL AS THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2779322 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION E008320

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention