BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA®

    MDR report key: 19654349 · Received July 2, 2024

    Report

    Report Number
    19654349
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 2, 2024
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HALF WAY THROUGH THE TREATMENT, THE MACHINE ALARMED WITH A BLOOD LEAK. PROCEDURE WAS STOPPED AND SPLATTERING WAS FOUND INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756428 SPECTRA OPTIA® SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. OPTIA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female