BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 5135298 · Received October 8, 2015

    Report

    Report Number
    1416980-2015-38299
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 14, 2015
    Report Date
    October 13, 2015
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION REVEALED THAT THE SEPTUM WAS COLLAPSED AT ONE SIDE. FUNCTIONAL LEAK TESTING WAS PERFORMED AND THERE WAS A LEAK COMING OUT OF THE SEPTUM WHERE IT WAS COLLAPSED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DUE TO USE ERROR. THE DEVICE WAS USED WITH A B BRAUN CATHETER, BUT IT¿S ONLY COMPATIBLE WITH THE INTERLINK CANNULA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK SYSTEM INJECTION SITE LEAKED. THIS OCCURRED WHEN UNSPECIFIED INTRAVENOUS FLUIDS WERE BEING PUSHED THROUGH THE DEVICE DURING INFUSION. THE REPORTER STATED THAT THE SEPTUM HAD TILTED SIDEWAYS IN THE PORT, WHICH ALLOWED FLUID TO LEAK OUT. 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
    665843 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1