BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY PUMP

    MDR report key: 696293 · Received October 10, 2005

    Report

    Report Number
    2921482-2005-00559
    Event Type
    Malfunction
    Date Received
    October 10, 2005
    Date of Event
    September 1, 2005
    Report Date
    September 21, 2005
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE HOMECARE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE, THE PUMP WAS PROGRAMMED IN THE CONTINUOUS MODE TO DELIVER VINCRISTINE AND ADRIAMYCIN IN THE CONTINUOUS RATE OF 0.5ML/HR FOR A DURATION OF FOUR DAYS. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE PUMP WAS CONNECTED TO THE PATIENT IN 08/2005. AFTER THE THIRD DAY OF THERAPY, THE PATIENT RETURNED TO THE HOSPITAL WITH AN EMPTY CONTAINER. THE PUMP WAS DISCONNECTED FROM THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other