BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 17341566 · Received July 18, 2023

    Report

    Report Number
    17341566
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 6, 2023
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RUNNING ON PLASMAPHERESIS, RECEIVED ALARM OF MOISTURE IN CENTRIFUGE DETECTED, OPENED CENTRIFUGE, AND FOUND BLOOD INSIDE COMPARTMENT WITH A BREAK IN THE CENTRIFUGE LINE ON THE YELLOW SIDE.

    Description of Event or Problem · 0

    PATIENT RUNNING ON PLASMAPHERESIS, RECEIVED ALARM OF MOISTURE IN CENTRIFUGE DETECTED, OPENED CENTRIFUGE, AND FOUND BLOOD INSIDE COMPARTMENT WITH A BREAK IN THE CENTRIFUGE LINE ON THE YELLOW SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142588 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC.
    740734 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown