BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 CHANNEL PUMP

    MDR report key: 16961 · Received October 19, 1994

    Report

    Report Number
    MW1003729
    Event Type
    Injury
    Date Received
    October 19, 1994
    Date of Event
    September 24, 1994
    Report Date
    September 26, 1994
    Manufacturer
    IMED CORP.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP MALFUNCTIONED WHILE INFUSING NIG AND DOBUTAMINE CAUSING PT TO BECOME HYPOTENSIVE. BASELINE 110/52. DECREASED TO 80/40. RETURNED TO BASELINE AFTER PLACING DRIPS ON NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 CHANNEL PUMP INFUSION DEVICE FRN IMED CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening