BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE 2991

    MDR report key: 7117000 · Received December 14, 2017

    Report

    Report Number
    7117000
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    July 12, 2017
    Report Date
    December 5, 2017
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RED BLOOD CELL REDUCTION OF A BONE MARROW PRODUCT ON THE COBE 2991 , A SMALL LEAK OCCURRED AT THE TOP OF THE WASH SET. MANUFACTURER RESPONSE FOR CELL PROCESSING SET FOR COBE 2991, CELL PROCESSING SET (PER SITE REPORTER):

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897335 COBE 2991 APPARATUS, AUTOTRANSFUSION CAC TERUMO BCT, INC. 04Z15002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other