BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 SP NEW

    MDR report key: 1840020 · Received September 16, 2010

    Report

    Report Number
    9615050-2010-00170
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 15, 2010
    Report Date
    August 18, 2010
    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
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE MFG FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES THAT ON 8/13/10 AT 1656, THE DEVICE WAS PROGRAMMED FOR INTERMITTENT DELIVERY, WITH A DOSE AMOUNT OF 100 ML, DOSE TIME 30 MIN, DOSE FREQUENCY 6 HOURS, NUMBER OF DOSES 4, KVO RATE 2 ML/HR, CONTAINER SIZE 460 ML, SET START TIME 1200. AT 1705, A NEW CONTAINER WAS SELECTED. BETWEEN 1709, AND 1715, THE DEVICE WAS POWERED ON AND OFF 3 TIMES. ON 8/15/10 AT 0718, THE DEVICE WAS POWERED ON AND A NEW DATE STAMP OCCURRED. AT 0727, A CASSETTE WAS INSERTED AND DELIVERY STARTED, DOSE 1 DELIVERY BEGAN, DELIVERY WAS STOPPED, 0.2 ML DELIVERED. AT 0728, A PRIMING VOLUME OF 6.4 ML OCCURRED. AT 0731, DELIVERY STARTED. AT 0801, DOSE 1 COMPLETED, 100 ML DELIVERED. AT 0801 KVO DELIVERY BEGAN. AT 1331, DOSE 2 DELIVERY BEGAN. AT 1401, DOSE 2 COMPLETED, 100 ML DELIVERED. AT 1605, DELIVERY WAS STOPPED AND A CHECK CASSETTE ALARM OCCURRED. AT 1608, THE DEVICE WAS POWERED OFF. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    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 CONCENTRATION OF VOSYN FOR INTERMITTENT DELIVERY, DOSE TIME 30 MIN, A FREQUENCY OF EVERY SIX HOURS, AND A KVO (KEEP VEIN OPEN) RATE OF 2 ML/HR. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE DELIVERY WAS SCHEDULED TO START ON (B)(6) 2010 AT 1200. ON (B)(6) 2010, AT 0730, THE NURSE REVIEWED THE PROGRAM AND PRESSED THE START BUTTON. AT THAT TIME, THE DEVICE STARTED TO DELIVER THE FIRST DOSE INSTEAD OF THE INTENDED KVO. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PT 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
    1 GEMSTAR 7 SP NEW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR