BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR PAIN MGE SNG

    MDR report key: 2191396 · Received July 27, 2011

    Report

    Report Number
    2921482-2011-00094
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 28, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CTR. A REVIEW OF THE HISTORY INDICATED ON (B)(6) 2011 AT 1348, THE DEVICE WAS PROGRAMMED IN THE CONTINUOUS ONLY DELIVERY IN ML, A 10ML/HR RATE, A 100ML CONTAINER. BETWEEN 1349 AND 1350, A 3.5ML PRIMING VOLUME WAS INDICATED, THE DEVICE WAS REPROGRAMMED WITH A MINIMUM RATE OF 1ML/HR, A MAXIMUM RATE OF 15ML/HR, THE DELIVERY WAS STARTED, AND STOPPED. BETWEEN 1353 AND 1643, THE DEVICE WAS STARTED 4 TIMES AND STOPPED 5 TIMES. BETWEEN 1644 AND 1657, TWO 5ML LOADING DOSES WERE DELIVERED. AT 2012, DELIVERY WAS STOPPED, A RATE OF 12ML/HR WAS PROGRAMMED AND THE DELIVERY WAS STARTED. AT 2156, AN ALMOST EMPTY ALARM OCCURRED AND SILENCED. BETWEEN 2226 AND 2230, AN EMPTY CONTAINER ALARM OCCURRED, SILENCED, DELIVERY WAS STOPPED, A NEW CONTAINER INDICATED A RATE OF 10ML WAS PROGRAMMED AND THE DELIVERY WAS STARTED. ON (B)(6) 2011, A NEW DATE STAMP OCCURRED. BETWEEN 0130 AND 0203, AN AIR IN LINE ALARM OCCURRED, THE DELIVERY WAS STOPPED, A START ALARM OCCURRED 2 TIMES AND SILENCED 10 TIMES. AT 0207, THE DEVICE WAS POWERED OFF. A REVIEW OF THE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED. 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 RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION, AT A RATE OF 10ML/HR AND A 100ML CONTAINER SIZE. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT 3 HOURS AFTER THE DELIVERY WAS STARTED, THE DEVICE ALARMED AND THE DISPLAY INDICATED 29ML HAD BEEN DELIVERED; HOWEVER, THE CONTAINER WAS EMPTY. 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
    1 GEMSTAR PAIN MGE SNG 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK