BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA COLLECTION SET

    MDR report key: 8089189 · Received November 20, 2018

    Report

    Report Number
    8089189
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 9, 2018
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SHORTLY AFTER PROCEDURE HAD STARTED, THE MACHINE ALARMED THAT THE CENTRIFUGE TUBING WAS TWISTED AND MACHINE PROMPT ME TO DISCONNECT PATIENT. UNABLE TO RETURN BLOOD IN TUBING. DRS. AND PTS COORDINATOR NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928370 SPECTRA OPTIA COLLECTION SET SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2877

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA