BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3832154 · Received May 27, 2014

    Report

    Report Number
    1416980-2014-16986
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    November 18, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET WOULD NOT FLOW. THIS OCCURRED DURING PATIENT INFUSION. THE REPORTER STATED THAT THE DEVICE WAS BEING USED IN A SETUP WHERE A PRIMARY SET WAS BEING PIGGYBACKED INTO THE LOWEST Y-SITE OF THE DEVICE. THE DEVICE WAS ALSO ATTACHED TO A TRANSFER DEVICE. 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
    310749 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PRIMARY SET| PHASEAL TRANSFER DEVICE