BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M

    MDR report key: 238758 · Received September 7, 1999

    Report

    Report Number
    238758
    Event Type
    Injury
    Date Received
    September 7, 1999
    Date of Event
    August 19, 1999
    Report Date
    August 31, 1999
    Manufacturer
    3M AVI, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE WAS CALLED TO ROOM BY PT WHO STATED THE PUMP WAS MAKING A STRANGE NOISE. THE PT HAD BEEN RECEIVING HYPERALIMENTATION AT 150CC/HR. WHEN ENTERING THE ROOM, THE NURSE NOTED THAT THE DISPLAY NUMBERS ON THE PUMP WERE ALL 888'S. AT THIS TIME THE CLICKING SOUND COULD BE HEARD FROM THE PUMP TO INDICATE IT WAS STILL PUMPING. THE LIGHT WAS ROTATING ALSO TO INDICATE THE PUMP WAS STILL WORKING. THE PUMP WAS IMMEDIATELY REPLACED WITH NO ADVERSE REACTION FROM THE PT. THE PUMP WAS RESET TO THE ORIGINAL NUMBERS AT THE NURSES STATION AND MAINTAIN THEM AT THAT TIME. THE PUMP WAS REMOVED FROM SVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M AVI 470 INFUSION PUMP FRN 3M AVI, INC. 470 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention