BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM SINGLE CHAN

    MDR report key: 299833 · Received October 6, 2000

    Report

    Report Number
    2921482-2000-00198
    Event Type
    Malfunction
    Date Received
    October 6, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 7, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN OVERDELIVERY. IT WAS REPORTED THAT THE PT WAS RECEIVING PPN 1000ML TO INFUSE AT 42ML/HR. THE CUSTOMER CONTACT STATES THAT THE INFUSION WAS EXPECTED TO BE COMPLETE AT 11:00AM, BUT WAS EMPTY AT 9:00AM. IT WAS REPORTED THAT THE RATE OF THE PPN WAS TO BE INCREASED TO 84ML/HOUR THAT DAY, BUT HAD NOT YET BEEN INCREASED. IT WAS REPORTED THAT THE MD WAS NOT CALLED, THE PUMP WAS REPLACED AND THERAPY CONTINUED WITHOUT EVENT. ACCORDING TO THE CUSTOMER CONTACT, THERE WAS NO ADVERSE EVENT OR HARM TO THE PT. THOUGH REQUESTED, THERE WAS NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XLM SINGLE CHAN INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other