BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE

    MDR report key: 15958500 · Received December 12, 2022

    Report

    Report Number
    15958500
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 30, 2022
    Report Date
    December 6, 2022
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN DOING AUTO STEM CELL COLLECTION WHEN THE MACHINE STOPPED AT MID CYCLE 14 AND ALARMED NOTING CENTRIFUGE LEAK AND BLOOD ALL OVER THE CENTRIFUGE. LEAK NOTED AT ONE OF THE CHAMBERS OF THE CENTRIFUGE PACK OF THE KIT USED WITH LOT #FA22G25121. PROCEDURE ABORTED. PIC MANAGER, BMT LAB AND COMPANY MADE AWARE. MANUFACTURER RESPONSE FOR APHERESIS BLOOD COLLECTION SET, AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE (PER SITE REPORTER). NOT KNOWN.

    Description of Event or Problem · 0

    RN DOING AUTO STEM CELL COLLECTION WHEN THE MACHINE STOPPED AT MID CYCLE 14 AND ALARMED NOTING CENTRIFUGE LEAK AND BLOOD ALL OVER THE CENTRIFUGE. LEAK NOTED AT ONE OF THE CHAMBERS OF THE CENTRIFUGE PACK OF THE KIT USED WITH LOT #FA22G25121. PROCEDURE ABORTED. PIC MANAGER, BMT LAB AND COMPANY MADE AWARE. MANUFACTURER RESPONSE FOR APHERESIS BLOOD COLLECTION SET, AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE (PER SITE REPORTER). NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130267 AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT FENWAL, INC. X6R2326 FA22G25121

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Male