BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVI 3M IV INFUSION PUMP

    MDR report key: 110867 · Received August 2, 1997

    Report

    Report Number
    2183161-1997-00023
    Event Type
    Other
    Date Received
    August 2, 1997
    Report Date
    July 17, 1997
    Manufacturer
    GRASEBY MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RETURNED FOR SERVICE, NOTED THAT DEVICE "FAILED FLOW RATE TEST". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 3M IV INFUSION PUMP IV INFUSION PUMP FRN GRASEBY MEDICAL, INC. 480 SP00134

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IV ADMINISTRATION SET