BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3023266 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07406
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY FOR EVALUATION WAS NOT SPECIFIED AT THE TIME OF THE INITIAL REPORTING. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR A CL CONTINU-FLO SOLN SET, 2 LAVS, L/L, THE LINE DETACHED ON ITS OWN. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127035 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1