BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ FLOW

    MDR report key: 33321 · Received June 5, 1996

    Report

    Report Number
    MW1009225
    Event Type
    Malfunction
    Date Received
    June 5, 1996
    Date of Event
    April 10, 1996
    Report Date
    May 16, 1996
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING INFUSION FOR PAIN MANAGEMENT. VIA EPIDURAL CATHETER WITH CONNECTION TO INFUSION PUMP. PUMP DID NOT INFUSE SOLUTION, ONLY 10CC OF PAIN MED INFUSED. PT DID NOT RECEIVE PAIN MED AS ORDERED FOR 5 DAYS. PUMP CHANGED AFTER VISIT WITH PHYSICIAN. NO TESTS OR LABS PERFORMED. PT DID NOT EXPERIENCE ADVERSE REACTIONS TO SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ FLOW INFUSION PUMP FRN GISH BIOMEDICAL, INC. ALPHA EZ FLOW 480

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR