BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA IDL SET

    MDR report key: 24321234 · Received February 12, 2026

    Report

    Report Number
    24321234
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 2, 2026
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CONNECTED TO OPTIA FOR STEM CELL COLLECTION. RN VISUALLY SPOTTED SLOW LEAK/DRIP COMING FROM THE SALINE FILTER ON THE OPTIA KIT. THE COLLECTION WAS PAUSED AND THE LMR [LABORATORY MANAGER/RESIDENT] WAS CALLED. PER LMR, COLLECTION IS TO BE DISCONTINUED, AND BLOOD IS NOT TO BE RE-INFUSED. PRODUCT WAS DISCONNECTED FROM OPTIA AND CRYOTHERAPY WAS CONTACTED. PATIENT WAS DISCONNECTED FROM OPTIA WITHOUT BLOOD BEING RE-INFUSED. VITAL SIGNS TAKEN AND CVC [CENTRAL VENOUS CATHETER] FLUSHED PER PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381209 SPECTRA OPTIA IDL SET SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 2509013441

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown