BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 8435880 · Received March 20, 2019

    Report

    Report Number
    8435880
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    December 4, 2018
    Report Date
    December 4, 2018
    Manufacturer
    FENWAL INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS RECEIVING THERAPEUTIC PLASMA EXCHANGE (TPE). WITH APPROXIMATELY 5 MINUTES LEFT ON TREATMENT, THE MACHINE ALARMED CENTRIFUGE LEAK. TREATMENT WAS IMMEDIATELY STOPPED. THE PATIENT WAS DISCONNECTED FROM THE MACHINE WITHOUT RETURNING PATIENT'S BLOOD. STAT HEMOGLOBIN AND HEMATOCRIT (H&H) WAS DRAWN AND PHYSICIAN WAS NOTIFIED. VITAL SIGNS WERE ASSESSED AND WERE STABLE. PATIENT WAS STABLE UPON LEAVING UNIT. THE MACHINE WAS TAKEN OUT OF SERVICE AND CASSETTE WAS PLACED IN RED BAG. FENWAL NOTIFIED OF CENTRIFUGE LEAK. FENWAL TECHNICIAN SCHEDULED TO LOOK AT MACHINE AND CASSETTE.

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING THERAPEUTIC PLASMA EXCHANGE (TPE). WITH APPROXIMATELY 5 MINUTES LEFT ON TREATMENT, THE MACHINE ALARMED CENTRIFUGE LEAK. TREATMENT WAS IMMEDIATELY STOPPED. THE PATIENT WAS DISCONNECTED FROM THE MACHINE WITHOUT RETURNING PATIENT'S BLOOD. STAT HEMOGLOBIN AND HEMATOCRIT (H&H) WAS DRAWN AND PHYSICIAN WAS NOTIFIED. VITAL SIGNS WERE ASSESSED AND WERE STABLE. PATIENT WAS STABLE UPON LEAVING UNIT. THE MACHINE WAS TAKEN OUT OF SERVICE AND CASSETTE WAS PLACED IN RED BAG. FENWAL NOTIFIED OF CENTRIFUGE LEAK. FENWAL TECHNICIAN SCHEDULED TO LOOK AT MACHINE AND CASSETTE.

    Description of Event or Problem · 1

    PATIENT WAS RECEIVING THERAPEUTIC PLASMA EXCHANGE (TPE). WITH APPROXIMATELY 5 MINUTES LEFT ON TREATMENT, THE MACHINE ALARMED CENTRIFUGE LEAK. TREATMENT WAS IMMEDIATELY STOPPED. THE PATIENT WAS DISCONNECTED FROM THE MACHINE WITHOUT RETURNING PATIENT'S BLOOD. STAT HEMOGLOBIN AND HEMATOCRIT (H&H) WAS DRAWN AND PHYSICIAN WAS NOTIFIED. VITAL SIGNS WERE ASSESSED AND WERE STABLE. PATIENT WAS STABLE UPON LEAVING UNIT. THE MACHINE WAS TAKEN OUT OF SERVICE AND CASSETTE WAS PLACED IN RED BAG. FENWAL NOTIFIED OF CENTRIFUGE LEAK. FENWAL TECHNICIAN SCHEDULED TO LOOK AT MACHINE AND CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230616 AMICUS SEPARATOR SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT FENWAL INC. 4R4580 FA18D10092

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA