BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3986810 · Received July 9, 2014

    Report

    Report Number
    3986810
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 9, 2014
    Manufacturer
    FENWAL, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    AUTOLOGOUS STEM CELL PRODUCT WAS COLLECTED FROM A PATIENT. DURING PROCESSING, THE BAG CONTAINING THE PRODUCT BROKE DURING CENTRIFUGATION. A SMALL AMOUNT OF THE PRODUCT LEAKED AND THE PRODUCT STERILITY MAY HAVE BEEN COMPROMISED.MANUFACTURER RESPONSE: THE FENWAL PLASMA PRODUCT PERFORMANCE REPORT HAS BEEN COMPLETED BY THE COMPANY. THE FENWAL POST MARKET QUALITY ASSURANCE TEAM HAS BEEN IN CONTACT WITH OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402860 * DISPOSABLE APHERESIS KIT KSR FENWAL, INC. * FA13 / 18099

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR CENTRIFUGE