BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 12623106 · Received October 13, 2021

    Report

    Report Number
    12623106
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    October 6, 2021
    Report Date
    October 7, 2021
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE SET-UP, THE ANTI-COAGULATION WAS NOT DETECTED IN THE TUBING AND WOULD NOT PASS SET-UP. THE SYSTEM WAS PULLED, AND A NEW SYSTEM USED SUCCESSFULLY. AS SUCH, THE PRODUCT DID NOT REACH THE PATIENT. THIS IS A REPEAT ISSUE, AND WE HAVE TWO SET-UPS WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525055 SPECTRA OPTIA SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 10220 20108113130 AND 2109013230

    Patients

    Seq Age Sex Outcome Treatment
    1