BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVI 200A

    MDR report key: 55482 · Received December 13, 1996

    Report

    Report Number
    MW1010404
    Event Type
    Malfunction
    Date Received
    December 13, 1996
    Date of Event
    December 3, 1996
    Report Date
    December 5, 1996
    Manufacturer
    3M INFUSION THERAPY
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A PROBLEM WITH THE PUMP ALARMING "OCCLUSION" AND THERE WAS NOTHING BLOCKING THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVI 200A INFUSION CONTROL PUMP FRN 3M INFUSION THERAPY AVI 200A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *