BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 4316107 · Received July 29, 2014

    Report

    Report Number
    3004548776-2014-00003
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 29, 2014
    Manufacturer
    FENWAL, INC.
    Product Code
    LKN
    PMA / PMN Number
    K111702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLASMA WASTE CONTAINER SHOULD BE EVALUATED FOR RBC CONTENT ANY TIME RBCS ARE NOTED OR THERE IS THE PRESENCE OF RED-TINGED FLUID IN THE PLASMA WASTE CONTAINER. FOR THE PROCEDURE IN QUESTION, THE INTERFACE SYSTEM FAILED TO FULLY CALIBRATE DUE TO AN ALARM CONDITION THAT OCCURRED DURING THE CALIBRATION SEQUENCE. UPON BEGINNING THE PROCEDURE, THE OPERATOR NOTED THE RBC'S IN THE RIGHT CASSETTE AND PLASMA WASTE CONTAINER. PER THE INSTRUCTIONS AND TRAINING ON THE AMICUS SEPARATOR, THE OPERATOR IMMEDIATELY HALTED THE PROCEDURE ONCE RBC'S WERE OBSERVED AND THE PROCEDURE WAS TERMINATED SHORTLY AFTER. A SECOND PROCEDURE WAS STARTED WITHOUT INCIDENT. RBC'S IN THE RIGHT CASSETTE AND PLASMA WASTE CONTAINER IS NOT UNCOMMON AND IS PART OF THE RISK PROFILE OF THE SYSTEM. THERE WERE NO PATIENT REACTIONS OR INJURY REPORTED WITH THIS EVENT. THIS IS THE FIRST CONFIRMED OCCURRENCE OF THIS SPECIFIC ISSUE RESULTING IN RBC'S OBSERVED BY THE OPERATOR IN THE RIGHT CASSETTE OR PLASMA WASTE CONTAINER. FENWALL WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS SPECIFIC CONDITION AS IT RELATED TO RBC'S IN THE RIGHT CASSETTE OR PLASMA WASTE CONTAINER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RIGHT CASSETTE AND PLASMA WASTE CONTAINER BEGAN FILLING WITH RED BLOOD CELLS (RBC'S) WITHIN THE FIRST FOUR MINUTES OF OPERATION. THE PROCEDURE WAS IMMEDIATELY HALTED AND THE OPERATOR CALLED THE TECHNICAL SUPPORT HOTLINE. THE CONDITION WAS ATTEMPTED TO BE CLEARED BY CHECKING THE DISPOSABLE. THE PROCEDURE WAS RESUMED WITH THE SAME RESULTS. THE PROCEDURE WAS DISCONTINUED AFTER A TOTAL COLLECTION TIME OF 7 MINUTES AND 15 SECONDS. ANOTHER PROCEDURE WAS IMMEDIATELY STARTED WITH A NEW DISPOSABLE KIT. THE CUSTOMER CALLED BACK TO INFORM THE TECHNICAL SUPPORT HOTLINE THAT THE SECOND PROCEDURE WAS RUNNING FINE. THERE WAS NO PATIENT REACTIONS OR INJURY REPORTED FOR EITHER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442787 AMICUS SEPARATOR SYSTEM AMICUS SEPARATOR SYSTEM LKN FENWAL, INC. 4R4580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other