BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVI 3M IV INFUSION PUMP

    MDR report key: 563375 · Received May 21, 2004

    Report

    Report Number
    2183502-2004-00034
    Event Type
    Malfunction
    Date Received
    May 21, 2004
    Report Date
    May 19, 2004
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALLEGED OVERINFUSION OF ACYCLOVIR. THE REPORT STATED THAT THEY "PUT THE FLUSH [0.9% SALINE] ONTO AN INFUSION OF ACYCLOVIR. CO SET THE LIMIT OF THE INFUSION AT 30MLS AND THE RATE AT 50ML/H SO THAT IT WOULD GO OVER ABOUT 40 MINS. WENT BACK TO TAKE IT DOWN AND THE WHOLE BAG [100 MLS] HAD GONE THROUGH EVEN THOUGH THE MACHINE SAID THAT ONLY 20 MLS HAD GONE THROUGH." INFUSION WAS DISCONTINUED AND PT WAS MONITORED. THERE WAS NO REPORTED INCIDENT RELATED MEDICAL SEQUELAE. THE REPORTING USER FACILITY TESTED THE OPERATION OF THE DEVICE AND COULD FIND NO FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 3M IV INFUSION PUMP IV INFUSION PUMP FRN SMITHS MEDICAL MD, INC. 270 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR