BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2823160 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04340
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET IN WHICH FLOW COULD NOT BE ESTABLISHED FROM THE UPPER MOST Y-SITE. ACCORDING TO THE REPORT, THE SET WAS PRIMED WITH NO ISSUES. HOWEVER, WHEN THE NURSE ATTEMPTED TO CONNECT A SECONDARY MEDICATION SET TO THE Y-SITE, FLOW COULD NOT BE ESTABLISHED. THE REPORTER INDICATED THAT SECONDARY SET WAS DISCONNECTED AND RECONNECTED AND FLOW WAS STILL NOT ESTABLISHED. THE PRIMARY SET WAS CHANGED OUT AND THERAPY CONTINUED AS NORMAL. THERE WERE NO REPORTS OF PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SECONDARY SET