BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 11692599 · Received April 20, 2021

    Report

    Report Number
    11692599
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 16, 2021
    Manufacturer
    TERUMO BCT, INC
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    APHERESIS: ANTICOAGULANT LINE APPEARED TO PRIME BUT COULD NOT BE DETECTED ON THE OPTIA MACHINE. THIS OCCURRED THREE CONSECUTIVE TIMES DESPITE TRADE OUT OF NEW LINES. IT OCCURRED PRIOR TO INTERACTION WITH THE PATIENT. ALL THREE SET-UPS WERE THE SAME LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590918 SPECTRA OPTIA APHERESIS SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC 2101263230

    Patients

    Seq Age Sex Outcome Treatment
    1