BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MINI-FUSER

    MDR report key: 1021533 · Received March 26, 2008

    Report

    Report Number
    6000001-2008-00194
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED "THAT THE ALARM DOES NOT WORK ALL THE TIME". THIS WAS FOUND DURING BIO-MED TESTING, WITH NO PATIENT INVOLVEMENT. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MINI-FUSER 80FRN FRN BAXTER HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1