BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 2180734 · Received May 5, 2011

    Report

    Report Number
    2921482-2011-00057
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 31, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.23ML FROM AN EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/- 1ML (+/- 5%). BASED ON THE DATA VERIFIED, HOSPIRA COULD NOT ATTRIBUTE THE ISSUE TO THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATED THAT ON (B)(4) 2010 AT 1408, THE DEVICE WAS PROGRAMMED FOR CONTINUOUS ONLY DELIVERY IN ML, AT A RATE OF 4.7ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 500ML, AND A 500ML CONTAINER SIZE. THE DEVICE WAS INTERMITTENTLY IN USE BETWEEN (B)(4) 2010 AND (B)(4) 2011, AT THE PROGRAMMED SETTING. ON (B)(4) 2011 BETWEEN 0429 AND 0434, A NEW CONTAINER WAS INDICATED AND THE DELIVERY WAS STARTED. A NEW DATE STAMP WAS INDICATED FOR (B)(4) 2011. AT 1030, THE DELIVERY WAS STOPPED AND THE DEVICE WAS POWERED OFF. 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 THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2010 AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER MILRINONE 400MCG/ML, AT A RATE OF 4.7ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 500ML, A 500ML CONTAINER SIZE. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE DURATION WAS EXPECTED TO BE 106 HOURS; HOWEVER, THE CONTAINER WAS CHANGED AFTER 96 HOURS ACCORDING TO THE USER FACILITY'S PROTOCOL. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT REPORTED THE DEVICE ALARMED FOR AN UNSPECIFIED ALARM CONDITION. AT THAT TIME, THE PATIENT NOTED THE CONTAINER WAS EMPTY SOONER THAN EXPECTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR