BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4192948 · Received October 22, 2014

    Report

    Report Number
    1416980-2014-36919
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RECEIVED AND THE LOT NUMBER IS UNKNOWN, A SAMPLE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET WAS NOT RECOGNIZED BY THE SIGMA SPECTRUM PUMP. THE PATIENT WAS BEING INFUSED WHEN THE PUMP ALARMED ¿TUBING NOT RECOGNIZED¿. THE SET HAD TO BE UNLOADED AND RELOADED INTO THE PUMP SEVERAL TIMES BEFORE IT WOULD RECOGNIZE THE TUBING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS IS REPORT 4 OF 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673941 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1