BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLF-PACK, REDI-FLO

    MDR report key: 1501178 · Received October 1, 2009

    Report

    Report Number
    MW5012917
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 29, 2009
    Report Date
    October 1, 2009
    Manufacturer
    WOLF-PAK
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ELASTOMERIC INFUSION PUMP INFUSED IN 45 MINUTES RATHER THAN THE 60 MINUTES THAT IT WAS SUPPOSE TO RUN OVER. PATIENT HAD INFUSION REACTION, INCLUDING FLUSHING, SHORTNESS OF BREATH AND FEVER, AND WAS SENT TO THE HOSPITAL. BENADRYL WAS ADMINISTERED. RED MAN'S SYNDROME SUSPECTED DUE TO FAST INFUSION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOLF-PACK, REDI-FLO ELASTOMERIC INFUSION PUMP MEB WOLF-PAK RFE100100 90214

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization