BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVI 3M IV INFUSION PUMP

    MDR report key: 367702 · Received December 18, 2001

    Report

    Report Number
    2183502-2001-00025
    Event Type
    Death
    Date Received
    December 18, 2001
    Report Date
    December 18, 2001
    Manufacturer
    SIMS DELTEC, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT CAME FROM THE REPORTER. THE FACILITY WHERE THE INCIDENT OCCURRED WAS A HOSPITAL. A FATAL OVERINFUSION WAS REPORTED. IT IS REPORTED AS A CASE OF USER ERROR. AN INFUSION OF AMINOPHYLLINE (A BRONCHO-DILATOR) WAS DELIVERED AT FIFTEEN TIMES THE INTENDED RATE. THE INCIDENT WAS DESCRIBED THAT THE ORIGINAL RATE OF THE PUMP WAS SET AT 500 ML/H TO DELIVER 250ML, BUT THE DEVICE WAS NOT RESET TO DELIVER THE MAINTENANCE DOSE OF 30ML/H. THE CORONER HAD REQUESTED THE PUMP BE EXAMINED. THE REPORTER BROUGHT THE PUMP TO THE DISTRIBUTOR FOR EVAL. AN EVAL OF THE DEVICE REPORTED THAT: THE UNIT WAS IN GOOD CONDITION AND WELL MAINTAINED (CAMS WERE LUBRICATED, SHOWED SLIGHT WARE). THE UNIT WAS TESTED PER FUNCTIONAL AND ACCURACY TESTS AS DESCRIBED IN THE SERVICE MANUAL, THE UNIT WAS FOUND TO PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57065 AVI 3M IV INFUSION PUMP IV INFUSION PUMP FRN SIMS DELTEC, INC. 270 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death