BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3113182 · Received May 8, 2013

    Report

    Report Number
    9615050-2013-01084
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 12, 2013
    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
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. THE CUSTOMER DID NOT PROVIDE AN EVENT DATE; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. 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 THE PT REC'D MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR BOLUS ONLY DELIVERY, OF MORPHINE 1MG/1ML, WITH 1MG BOLUS DOSE, A 5 MIN PT LOCKOUT, NO DOSE LIMIT WAS SELECTED, A 100ML CONTAINER SIZE AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WHERE PROVIDED. NO FURTHER PROGRAMMING PARAMETERS WHERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THE CONTAINER WAS EMPTY. IT WAS REPORTED THAT APPROX 75ML WAS EXPECTED TO BE REMAINING. AT THAT TIME, A SMALL AMOUNT OF FLUID WAS NOTED ON THE FLOOR; HOWEVER, IT WAS REPORTED THAT NO LEAKAGE WAS NOTED FROM THE CONTAINER OR THE TUBING SET. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THE PT WAS REPORTED TO BE ALERT AND NOT SEDATED. NO MEDICAL INTERVENTIONS WERE REPORTED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202432 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK