BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3981341 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25373
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    April 25, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN ACCESS PRIMARY SET EXPERIENCED BACKFLOW DURING PATIENT INFUSION. THE REPORTER STATED THAT THE SET WAS CONNECTED TO A PRIMARY BAG AND THE PATIENT, AND SIX HOURS LATER, THE NURSE NOTICED LIPIDS WERE BACKING UP INTO THE "DRIPS", PAST THE CHECK VALVE. THE SET WAS THEN REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458255 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1