BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 10829103 · Received November 12, 2020

    Report

    Report Number
    10829103
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    September 13, 2020
    Report Date
    September 28, 2020
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PRIMING THE PLEX APHERESIS CASSETTE, TUBING WAS NOTED TO BE LEAKING FROM THE AREA NEAR WHERE THE TUBING ENTERS THE CASSETTE. THERE WAS LEAKING FROM ONE PIECE OF TUBING ONLY (NOT BOTH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295904 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2003123330

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA