BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERAPH 100

    MDR report key: 22023605 · Received May 15, 2025

    Report

    Report Number
    3014015528-2025-00010
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 8, 2024
    Report Date
    February 21, 2025
    Manufacturer
    EXTHERA MEDICAL CORPORATION
    Product Code
    QLO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS STATED IN THE NYT, SEE CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, JANUARY 23, 2025. THE MANUFACTURER FOLLOWED UP WITH THE FACILITY IN ANTIGUA WHERE THE CLAIMED ADVERSE EVENTS TOOK PLACE AND WITH THE TREATING PHYSICIAN. THE FACILITY HAS STATED THAT IT WAS NOT AWARE OF ANY ADVERSE EVENTS. THE PHYSICIAN HAS NOT RESPONDED.

    Description of Event or Problem · 0

    THIS INFORMATION WAS REPORTED PUBLICLY BY THE NEW YORK TIMES. SEE CARREYROU, JOHN. "A START-UP CLAIMED ITS DEVICE COULD CURE CANCER. THEN PATIENTS BEGAN DYING." THE NEW YORK TIMES, JANUARY 23, 2025. PATIENT P3 (MALE, 47, DIAGNOSED WITH METASTATIC RECTAL AND LIVER CANCER) EXPERIENCED THREE CLOGGED FILTERS DURING HIS FIRST TREATMENT WITH SERAPH 100 ON APRIL 8TH. TREATMENT CONTINUED WITH THE FOURTH FILTER WITHOUT CLOGGING. THE REPORTER SUGGESTS THE CLOGS MAY BE CAUSED BY EITHER A LARGE QUANTITY OF CIRCULATING TUMOR CELLS AND OTHER PATHOGENS FROM THE PATIENT OR BY THE TREATMENT FLOW RATE BEING SET TOO LOW. ACCORDING TO THE ARTICLE, VIDEO TAKEN OF ANOTHER PATIENT RECEIVING THE SAME TREATMENT NEAR THIS TIME SHOWED THE FLOW RATE WAS SET AT 80 ML/MIN. THE SERAPH 100 IFU SPECIFIES A FLOW RATE OF 150 ML/MIN FOR PRIMING AND 100-350 ML/MIN DURING TREATMENT. THE ARTICLE STATES THAT THESE TREATMENTS TOOK PLACE OUTSIDE THE UNITED STATES, IN ANTIGUA. THE DEVICE WAS BEING USED OFF-LABEL FOR THE TREATMENT OF CANCER, OUTSIDE OF THE UNITED STATES IN ANTIGUA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812869 SERAPH 100 SERAPH 100 QLO EXTHERA MEDICAL CORPORATION 50001-EUA K007121

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention