BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 5993401 · Received October 3, 2016

    Report

    Report Number
    1416980-2016-15849
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Report Date
    November 10, 2016
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE - THE PRODUCT CODE WAS REPORTED TO BE EITHER 2C8519 OR 2C8419. THE 510(K) NUMBER - THE 510(K) NUMBER FOR 2C8519 IS K961225. THE 510(K) NUMBER FOR 2C8419 IS K112893. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROLLER CLAMP OF A CLEARLINK SOLUTION SET WAS NOT OCCLUDING FLOW WHEN THOUGHT TO BE COMPLETELY CLOSED. THIS OCCURRED DURING PRIMING, AND LED TO SOLUTION LEAKING OUT OF THE SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646226 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1