BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3903004 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20894
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNKNOWN PUMP INVOLVED ALARMED FOR UPSTREAM OCCLUSION DURING THE EVENT. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECONDARY SET STOPPED INFUSING. THIS OCCURRED DURING INFUSION OF AN UNKNOWN ANTIBIOTIC DRUG. THE DEVICE WAS BEING USED WITH AN UNKNOWN INFUSION PUMP. THE REPORTER STATED THAT THE SET LOOKED ¿LIKE IT IS "DRIPPING," BUT THAT WHEN "THEY" CAME BACK TO THE ROOM, THE ENTIRE ANTIBIOTIC DID NOT INFUSE.¿ THERE WAS NO 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
    380700 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INFUSION PUMP| UNKNOWN ANTIBIOTICS