BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 3113113 · Received May 9, 2013

    Report

    Report Number
    9615050-2013-01127
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 11, 2013
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE WAS NOT IN USE ON THE REPORTED EVENT DATE OF (B)(6) 2013. THE DEVICE WAS PROGRAMMED ON (B)(6) 2013 AT 1234, TO DELIVERY WEIGHT DOSED IN MCG/KG/MIN, WITH A SET PATIENT WEIGHT OF (B)(6), A SET CONCENTRATION OF 139 MG/200 ML, A RATE OF 0.375 MG/K/MIN, AND A CONTAINER SIZE OF 200 ML. AT 1644, THE DELIVERY WAS STARTED. THE DEVICE CONTINUED IN USE INTERMITTENTLY AT THE PROGRAMMED SETTINGS. ON (B)(6) 2013 AT 0843, AN EMPTY CONTAINER IS INDICATED AND KVO DELIVERY BEGAN. AT 0855, THE DELIVERY WAS STOPPED, A NEW CONTAINER IS INDICATED AND THE DELIVERY IS STARTED. AT NEW DATE STAMP OF (B)(6) 2013 OCCURRED. AT 1445, THE DELIVERY WAS STOPPED, A START ALARM OCCURRED AND WAS SILENCED. AT 1449, A CHANGE BATTERY ALARM OCCURRED AND THE DEVICE WAS POWERED ON USING BATTERIES. 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 PATIENT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER MILRINONE 139 MG/200 ML, AT A RATE OF 2.5 ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 250 ML AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE DELIVERY WAS EXPECTED TO BE COMPLETED IN 80 HOURS. AFTER APPROX. 70 HOURS, THE PATIENT'S SPOUSE NOTED THE MEDICATION CONTAINER WAS EMPTY. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. AFTER AN UNSPECIFIED LENGTH OF TIME THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204889 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR