BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 3678819 · Received March 7, 2014

    Report

    Report Number
    3678819
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    January 31, 2014
    Report Date
    March 7, 2014
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING KIT FOR OPTIA TPE (THERAPEUTIC PLASMA EXCHANGE) MALFUNCTIONED DURING PROCEDURE; LOUD BANG HEARD, WHITE UPPER PLASTIC BRACE HOUSING NOTED TO BE SHREDDED. PROCEDURE ABORTED AND NEW TUBING KIT SET UP. PATIENT DID NOT RECEIVE RINSEBACK; APPROXIMATELY 195 CCS OF WB NOT RETURNED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138768 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. * 05V3229

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMMUNOTHERAPY