BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR DOCKING STATION

    MDR report key: 2921846 · Received January 15, 2013

    Report

    Report Number
    3008785455-2013-00008
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    August 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    HOSPIRA INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF THE DEVICE DID NOT DELIVER. ON UNSPECIFIED DATES, IT WAS REPORTED THAT GEMSTAR PUMPS AND GEMSTAR BOLUS CORDS WERE CONNECTED TO GEMSTAR DOCKING STATIONS AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE BOLUS CORDS WERE NOT WORKING. THE DOCKING STATIONS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICES WERE IN CLINICAL USE. UPON VISUAL EXAMINATIONS IN THE BIOMEDICAL ENGINEERING DEPARTMENT, IT WAS NOTED THAT AN UNSPECIFIED NUMBER OF PINS WERE MISSING FROM THE BOLUS CORD CONNECTOR PORT OF THE DOCKING STATIONS. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23045 GEMSTAR DOCKING STATION 80FRN FRN HOSPIRA INC. NA UNKG1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GEMSTAR PUMP: LIST #UNK, SN UNK| GEMSTAR BOLUS CORD: LIST #13026, LOT #UNK