BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA®

    MDR report key: 19688862 · Received July 8, 2024

    Report

    Report Number
    19688862
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    March 12, 2024
    Report Date
    March 20, 2024
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A ROUTINE PLASMA EXCHANGE THE CONNECTION (LUER TYPE) BETWEEN THE APHERESIS SET AND THE WARMER TUBING SET VIBRATED LOOSE ALLOWING < 100 ML OF BLOOD LOSS. DURING SETUP THIS OPERATOR ENSURED THE CONNECTION WAS VERY TIGHT (AS THIS INCIDENT HAS HAPPENED BEFORE) AND WHEN LEAK WAS DISCOVERED IT WAS FOUND TO BE "FINGER TIGHT." THERE WAS NO COMPLETE SEPARATION OF THE LINES, BUT ENOUGH THAT BLOOD WAS ALLOWED TO LEAK OUT VIA THE THREADED CONNECTION. THE CONNECTION WAS RE-TIGHTENED AND MONITORED THE REMAINDER OF THE PROCEDURE. PATIENT WAS STABLE THROUGHOUT, NO CHANGES IN HGB/HCT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894686 SPECTRA OPTIA® SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 12220 2308213241

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male