BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 21956893 · Received May 4, 2025

    Report

    Report Number
    3014015528-2025-00021
    Event Type
    Injury
    Date Received
    May 4, 2025
    Report Date
    May 2, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER RECOGNIZED THAT THE DEVICE WAS USED ON A PEDIATRIC PATIENT, WHICH IS OFF-LABEL, AND THAT MAY HAVE CONTRIBUTED THE EVENT.

    Description of Event or Problem · 0

    PATIENT RECEIVED THREE SEPARATE SERAPH 100 TREATMENTS IN CONJUNCTION WITH ECMO AND CRRT (PRISMAFLEX HF 1000 SET) ON DAYS 39, 40, AND 42 AFTER AUTOLOGOUS HEMATOPOIETIC CELL TRANSPLANTATION (HCT) (EACH SERAPH TREATMENT LASTING 24 HOURS, OR 68 HOURS TOTAL). CITRATE USED AT 150 ML/HOUR AND BLOOD FLOW RATE SET TO 150 ML/MIN. EFFECT ON COAGULATION WAS ASSESSED WITH ACTIVATED PARTIAL THROMBOPLASTIN (APTT) TESTS. NOTE THAT HEPARIN AND BIVALIRUDIN WERE NOT USED BECAUSE SIGNIFICANT AUTO-ANTICOAGULATION WAS OBSERVED BEFORE TREATMENT. DURING THE 2ND TREATMENT OF THREE TREATMENTS, PATIENT EXPERIENCED ELEVATED APTT TEST TIME (90S VS REFERENCE (B)(4)) NOTED 4H AFTER START OF 2ND TREATMENT. RESOLVED 12H AFTER TREATMENT ENDED WITHOUT FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871533 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Male Other ANTIVIRAL VALGANCICLOVIR| CEFEPIME| CIDOFOVIR| CITRATE| CRRT PRISMAFLEX HF1000 SET| ECMO| EMAPALUMAB AND ECULIZUMAB| GANCICLOVIR| IV DEXAMETHASONE| WEEKLY IV IMMUNOGLOBULIN