BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE

    MDR report key: 15958476 · Received December 12, 2022

    Report

    Report Number
    15958476
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 14, 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

    THE ALLOGENIC STEM CELL COLLECTION WAS NEARING THE END OF THE DAY. THE PATIENT WAS IN CYCLE NUMBER 11 OF THE 12 PLANNED CYCLES. THE APHERESIS RN RECEIVED A CENTRIFUGE LEAK ALARM AND NOTED BLOOD LEAK IN THE CENTRIFUGE COMPARTMENT. THE PRODUCT AND PLASMA BAGS WERE IMMEDIATELY CLAMPED. THE PROCEDURE WAS ABORTED DUE TO THIS LEAK. UNFORTUNATELY THE PATIENT COULD NOT HAVE RE-INFUSION OF BLOOD BACK AT THE END OF THE PROCEDURE AS THE STERILE KIT HAD BEEN BREACHED. A POST CBC WAS DRAWN. THE PATIENT WAS STABLE AND THE HAPPENINGS WERE EXPLAINED TO HER. MANUFACTURER RESPONSE FOR STEM CELL COLLECTION KIT, AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE (PER SITE REPORTER) UNKNOWN.

    Description of Event or Problem · 0

    THE ALLOGENIC STEM CELL COLLECTION WAS NEARING THE END OF THE DAY. THE PATIENT WAS IN CYCLE NUMBER 11 OF THE 12 PLANNED CYCLES. THE APHERESIS RN RECEIVED A CENTRIFUGE LEAK ALARM AND NOTED BLOOD LEAK IN THE CENTRIFUGE COMPARTMENT. THE PRODUCT AND PLASMA BAGS WERE IMMEDIATELY CLAMPED. THE PROCEDURE WAS ABORTED DUE TO THIS LEAK. UNFORTUNATELY THE PATIENT COULD NOT HAVE RE-INFUSION OF BLOOD BACK AT THE END OF THE PROCEDURE AS THE STERILE KIT HAD BEEN BREACHED. A POST CBC WAS DRAWN. THE PATIENT WAS STABLE AND THE HAPPENINGS WERE EXPLAINED TO HER. MANUFACTURER RESPONSE FOR STEM CELL COLLECTION KIT, AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204798 AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT FENWAL, INC. X6R2326 FA22G25121

    Patients

    Seq Age Sex Outcome Treatment
    1 22265 DA Female Other