BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERAPH 100

    MDR report key: 21957070 · Received May 4, 2025

    Report

    Report Number
    3014015528-2025-00022
    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. PATIENT EXPERIENCED HEMATOCHEZIA (BLOOD IN STOOL) DURING THE 3RD OF 3 TREATMENTS. ELEVATED APTT TEST TIME (176S VS REFERENCE 25-37S) NOTED 1H AFTER START OF 3RD TREATMENT. RESOLVED 12H AFTER TREATMENT ENDED WITHOUT FURTHER INTERVENTION. CONCERNS ABOUT BLEEDING PROMPTED UPPER ENDOSCOPY WITH BIOPSY AND LED TO HALTING OF FURTHER TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468648 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA

    Patients

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