BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3142881 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14102
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK IV SET HAD CONCURRENT FLOW BETWEEN THE PRIMARY AND SECONDARY SOLUTION BAGS. THE REPORT INDICATED THAT THE NURSES EXECUTED PROPER SET UP TECHNIQUE FOR THE SECONDARY INFUSION. THIS OCCURRED DURING PATIENT INFUSION, HOWEVER NO ADVERSE EVENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243144 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1