BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLEX 300I DISPOSABLE SET

    MDR report key: 236507 · Received August 13, 1999

    Report

    Report Number
    2030437-1999-00003
    Event Type
    Malfunction
    Date Received
    August 13, 1999
    Date of Event
    May 27, 1999
    Report Date
    June 7, 1999
    Manufacturer
    NEXELL THERAPEUTICS INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ISOLEX 300I PROCEDURE, CONNECTION OF FILTRATE LINE TO SPINNER DETACHED ON ISOLEX 300E DISPOSABLE SET. CELLS WERE RECOVERED AND PROCEDURE RESTARTED WITH NEW DISPOSABLE SET. DUE TO LOW YIELD ON FINISHED PRODUCT, THE PT WAS REMOBILIZED, COLLECTED, AND REINFUSED. PT DOING FINE AT THIS TIME. INVESTIGATION ON RETURNED DISPOSABLE SET IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLEX 300I DISPOSABLE SET STEM CELL SELECTION SYSTEM GKT NEXELL THERAPEUTICS INC. R4R9525 H99B22481RGM

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN