BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2830829 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-05052
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND AN 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 BAXTER SALES REPRESENTATIVE (BSR) REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A CLEARLINK CONTINU-FLO SOLUTION SET IN WHICH A NURSE STATED THAT SHE EXPERIENCED AN INCREASED AMOUNT OF AIR IN THE LINE EVEN AFTER THE SET HAD BEEN PRIMED. THE BSR INDICATED THAT THE FACILITY RECENTLY CONVERTED TO BAXTER PRODUCTS FROM (B)(4). THE NURSE PRIMED THE SET AND INVERTED AND TAPPED THE CHECK VALVE PER LABEL COPY. THE BSR PERFORMED AN ADDITIONAL IN-SERVICING AND DIRECTED THE STAFF TO INVERT AND TAP THE Y-SITES. THE FACILITY WAS ALSO DIRECTED TO INVERT AND TAP THE CHECK VALVE AT THE END OF PRIMING. SINCE THE IN-SERVICE, THE FACILITY HAS NOT OBSERVED ANY AIR IN LINE ISSUES. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT, 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