BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ FLOW

    MDR report key: 33320 · Received June 5, 1996

    Report

    Report Number
    MW1009224
    Event Type
    Malfunction
    Date Received
    June 5, 1996
    Date of Event
    May 12, 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 PAIN MEDICATION VIA EPIDURAL CATHETER THROUGH INFUSION PUMP. PT CALLED AGENCY TO NOTIFY THAT IV BAG WAS EMPTY AND PUMP WAS NOT FUNCTIONING PROPERLY. NURSE SENT OUT TO REPROGRAM AND INVESTIGATE PUMP. NURSE NOTED SCREENS WITH JUMBLED SYMBOLS AND WOULD NOT PROGRAM PROPERLY. PUMP RETURNED TO PHARMACY FOR REPLACEMENT PUMP. PT HAD NO C/O ADVERSE DRUG REACTION OR SIGNS/SYMPTOMS OF DRUG TOXICITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR