BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA APHERESIS SYSTEM

    MDR report key: 1019251 · Received March 13, 2008

    Report

    Report Number
    1019251
    Date Received
    March 13, 2008
    Date of Event
    December 16, 2007
    Report Date
    March 10, 2008
    Manufacturer
    GAMBRO BCT, INC.
    Product Code
    LKN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE APHERESIS MACHINE WAS ALARMING HIGH CENTRIFUGE PRESSURE AND WOULD NOT CLEAR. THE TREATMENT WAS TERMINATED AND THE MACHINE WAS PULLED FROM SERVICE. THE DEVICE WILL ALARM HIGH CENTRIFUGE PRESSURE IF THE CENTRIFUGE CHAMBER IN THE PATIENT CIRCUIT IS NOT POPERLY SEATED IN PLACE BEFORE TREATMENT IS STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA OPTIA APHERESIS SYSTEM APHERESIS MACHINE LKN GAMBRO BCT, INC. SPECTRA *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR