BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS MNC APHERESIS KIT ¿ DOUBLE NEEDLE

    MDR report key: 16042164 · Received December 23, 2022

    Report

    Report Number
    16042164
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    December 13, 2022
    Report Date
    December 14, 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

    DURING CYCLE #11 OF PLANNED 12 CYCLE AUTOLOGOUS STEM CELL COLLECTION A CENTRIFUGE BLOOD LEAK OCCURRED. THE PROCEDURE WAS IMMEDIATELY ABORTED. THE HPC, APHERESIS CELLS AND PLASMA WERE SEALED AND SENT TO THE BMT LAB AND NOT SUSPECTED TO BE CONTAMINATED. THE PATIENT WAS UNABLE TO HAVE A RE-INFUSION OF BLOOD POST PROCEDURE DUE TO THE STERILITY OF THE KIT BEING BREACHED. THE PATIENT HAD STABLE VITAL SIGNS POST COLLECTION. A POST CBCD WAS DRAWN AND SENT. NO BLOOD TRANSFUSION POST COLLECTION IS REQUIRED FOR HIM. MANUFACTURER RESPONSE FOR APHERESIS KIT, AMICUS MNC APHERESIS KIT ¿ DOUBLE NEEDLE (PER SITE REPORTER). FRESENIUS KABI WAS NOTIFIED VIA PHONE CALL AND ONLINE SUBMITTED KIT PERFORMANCE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726150 AMICUS MNC APHERESIS KIT ¿ DOUBLE NEEDLE SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT FENWAL, INC. X6R2326 FA22G25121

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Male