BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY PUMP

    MDR report key: 1061825 · Received June 13, 2008

    Report

    Report Number
    2921482-2008-00191
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 19, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K023062
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE, THE DEVICE WAS PROGRAMMED TO DELIVER 2500 ML OF TPN FOR A DURATION OF 24 HR WITH A 2 HOUR TAPER UP AND A 2 HOUR TAPER DOWN. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IN 2008, THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE SOUNDED AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE PATIENT'S WIFE CONTACTED THE USER FACILITY AND WAS INSTRUCTED TO DISCONNECT THE TUBING SET FROM THE PORT. AT THIS TIME, THE PATIENT'S WIFE NOTED BLOOD HAD BACKED UP INTO THE PORT. THE PORT COULD NOT BE FLUSHED. ON AN UNSPECIFIED DATE, THE PT WAS ADMITTED TO THE HOSPITAL AND THE PORT WAS REPLACED. ON AN UNSPECIFIED DATE, THE PT WAS DISCHARGED HOME WHERE THE THERAPY WAS CONTINUED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT Hospitalization GEMSTAR SET| UNSPECIFIED PORT