BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVI 3M IV INFUSION PUMP

    MDR report key: 149932 · Received February 11, 1998

    Report

    Report Number
    2183161-1998-00001
    Event Type
    Death
    Date Received
    February 11, 1998
    Date of Event
    January 16, 1998
    Report Date
    January 19, 1998
    Manufacturer
    GRASEBY MEDICAL INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A REQUEST FOR SERVICE ACTION, BIO-MEDICAL TECHNICIAN REPORTED THAT AN ELDERLY PATIENT (77?) HAD DIED WHILE RECEIVING INFUSION FROM THE AVI INFUSION PUMP. IT IS ALLEGED THAT HE DEVICE INFUSED AT TWICE THE RATE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 3M IV INFUSION PUMP IV INFUSION PUMP FRN GRASEBY MEDICAL INC. 840 MA93630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death IV ADMINSTRAION SET.