BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3964609 · Received May 30, 2014

    Report

    Report Number
    9615050-2014-03756
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE HOMECARE PATIENT REPORTED RECEIVING MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CHEMOTHERAPY MEDICATION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. ON AN UNSPECIFIED DATE AT 1430, THE PATIENT REPORTED THE DELIVERY WAS STARTED AT THE PHYSICIANS OFFICE AND THE PATIENT WAS SENT HOME. AT APPROXIMATELY 2400, THE DEVICE ALARMED THE DELIVERY WAS COMPLETE. AT THAT TIME, THE PATIENT REPORTED THE CONTAINER WAS EMPTY; HOWEVER, THE DELIVERY WAS EXPECTED TO BE COMPLETED AT 0830 WHICH WAS THE SCHEDULED TIME TO RETURN TO THE PHYSICIANS OFFICE. THE PATIENT RETURNED TO THE PHYSICIANS OFFICE AS SCHEDULED AND THE DEVICE WAS DISCONNECTED FROM THE PATIENT. THE PATIENT REPORTED THERE WERE NO ADVERSE EFFECTS. NO MEDICAL INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319825 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR