BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLM SINGLE CHAN

    MDR report key: 480732 · Received August 22, 2003

    Report

    Report Number
    2921482-2003-00442
    Event Type
    Malfunction
    Date Received
    August 22, 2003
    Date of Event
    August 1, 2003
    Report Date
    August 5, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KDZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A PATIENT RECEIVING AN OVER-DELIVERY OF CARDIZEM. THE DEVICE WAS PROGRAMMED TO DELIVER A 100ML BAG OF CARDIZEM AT A RATE OF 10ML/HR. THE CUSTOMER COULD NOT RECALL THE INFUSION START TIME. IT WAS REPORTED THAT THE NURSE LEFT THE PATIENT'S ROOM AND APPROXIMATELY FIVE MINUTES LATER THE PUMP ALARMED THAT THE INFUSION WAS COMPLETE. THE CUSTOMER HAD NO SPECIFIC PATIENT INFORMATION; HOWEVER, IT WAS REPORTED THAT THE PATIENT'S VITAL SIGNS REMAINED STABLE AND NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other