BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY IN

    MDR report key: 3750187 · Received December 26, 2013

    Report

    Report Number
    9615050-2013-06346
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    November 26, 2013
    Report Date
    November 26, 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
    CA
    Reporter Occupation
    NURSE

    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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN THERAPY FOLLOWING AN ALARM CONDITION. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR INTERMITTENT DELIVERY OF AN UNSPECIFIED MEDICATION AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THE PT WAS TO RECEIVE 3 DOSES PER DAY. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED INCLUDING THE DOSE FREQUENCY. AT APPROX 1600, THE HOMECARE PT REPORTED TO THE HOMECARE NURSE THAT THE SCHEDULE DOSE WAS MISSED DUE TO THE DEVICE ALARMING WITH A 09/001/0041 (BACKWARD MOTOR MOVEMENT) SERVICE ALARM CODE. AT 2100, THE HOMECARE NURSE WENT TO THE PT'S HOME. AT THAT TIME, THE NURSE REPORTED TROUBLE SHOOTING THE DEVICE; HOWEVER, THE DEVICE ALARMED WITH A 09/001/0041 SERVICE ALARM CODE. THE DEVICE WAS REMOVED FROM CLINICAL USE. THE NURSE INSTRUCTED THE PT TO GO TO THE EMERGENCY DEPARTMENT TO HAVE THE DOSE DELIVERED; HOWEVER, THE PT DECLINED. THE PT INDICATED HAVING A SCHEDULED APPOINTMENT AT THE HOSPITAL THE NEXT DAY AT 0800 AND THE THERAPY WOULD BE RESUMED USING A REPLACEMENT DEVICE AT THAT TIME. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675785 GEMSTAR 7 THERAPY IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK