BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD PRIZM

    MDR report key: 2171215 · Received September 19, 2006

    Report

    Report Number
    MW5021380
    Event Type
    Injury
    Date Received
    September 19, 2006
    Date of Event
    August 14, 2006
    Report Date
    September 15, 2006
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CADD PUMP WITH 5-FU DISPENSED TO MD OFFICE FOR ADMIN. REC'D A CALL FROM HOME HEALTH RN THAT PUMP HAD STOPPED PUMPING AFTER ONE HR. PUMP HISTORY REVEALED PUMP PROGRAMMING ERROR AND PT REC'D 46-HR INFUSION IN ONE HR. MD NOTIFIED. PT SEEN BY MD THE NEXT DAY. PT SUBSEQUENTLY HOSPITALIZED ON 08/25. OBTAINED H AND P FROM HOSPITAL DEMONSTRATING REASON FOR HOSPITALIZATION DUE TO SEVERE MUCOSITIS AND PANCYTOPENIA. (B)(4). APPROXIMATE AGE OF DEVICE: 1 YR. LOCATION WHERE EVENT OCCURRED: OUTPATIENT TREATMENT FACILITY AND MD'S OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PRIZM AMBULATORY INFUSION PUMP FRN SMITHS MEDICAL 6101

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization OTHER CHEMOTHERAPY AGENTS THROUGH MD'S OFFICE