BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2830786 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-05044
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE CONTACTED BAXTER PRODUCT SURVEILLANCE TO REPORT A QUANTITY OF FOUR CONTINU-FLO SOLUTION SETS IN WHICH THE FACILITY REPRESENTATIVE WAS UNABLE TO PRIME THE SET. ACCORDING TO THE REPORT, THIS WAS DISCOVERED DURING SET-UP. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12G17112

    Patients

    Seq Age Sex Outcome Treatment
    1