BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR SP INFUSION

    MDR report key: 3252539 · Received July 25, 2013

    Report

    Report Number
    9615050-2013-02177
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 1, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 CUSTOMER CONTACT REPORTED THAT THE DEVICE POWERED OFF BY ITSELF WITH AN INADEQUATE RESPONSE TIME FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. THE DEVICE WAS CONNECTED TO A DOCKING STATION. ON (B)(6) 2013 AT APPROXIMATELY 2030, THE CUSTOMER CONTACT REPORTED THAT THE DEVICE ALARMED FOR POWER LOSS. AT THAT TIME, THE DEVICE IMMEDIATELY POWERED OFF AND WOULD NOT POWER BACK ON. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING REVIEW OF THE HISTORY BY THE CUSTOMER CONTACT AT THE USER FACILITY, AN ERROR CODE 15/000/001 (POWER DOWN ERROR) WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348922 GEMSTAR SP INFUSION 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR GEMSTAR DOCKING STATION: LIST #13075, LOT #UNK