BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 1760923 · Received July 14, 2010

    Report

    Report Number
    2921482-2010-00509
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.29ML 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 PUMP HISTORY WAS DOWNLOADED AT THE MANUFACTURING SITE. ON (B)(6) 2010 AT 1011, THE DEVICE WAS PROGRAMMED FOR TPN WITH TAPER UP AND DOWN, WITH A 250ML VTBI (VOLUME TO BE INFUSED), A 1HR TAPER UP, 1HR TAPER DOWN, FOR A TOTAL TPN TIME OF 5HRS, AND A 250ML CONTAINER SIZE. A 7.2ML PRIMING VOLUME IS INDICATED. AT 1014 THE INFUSION WAS STARTED AND FROM 1014 TO 1114, THE TAPER UP OCCURRED. AT 1414, THE TAPER DOWN BEGAN. AT 1446, AN EMPTY CONTAINER ALARM OCCURRED. BETWEEN 1446 & 1504, THE SILENCE KEY WAS PRESSED 10 TIMES AND THE INFUSION WAS STOPPED. AT 1506, THE DEVICE WAS POWERED OFF. REVIEW OF THE HISTORY FOUND THE AMOUNT INFUSED WAS 242.8ML AND THE PRIMING VOLUME WAS 72 ML WHICH EQUALS THE CONTAINER SIZE OF 250ML. THE PUMP DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TPN (TOTAL PARENTERAL NUTRITION) AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT REPORTED THE PUMP DISPLAY INDICATED THE DELIVERY WAS COMPLETE; HOWEVER, THERE WAS AN UNSPECIFIED VOLUME OF FLUID REMAINING IN THE BAG. THE CUSTOMER CONTACT REPORTED THE BAGS WERE OVERFILLED WITH AN UNSPECIFIED AMOUNT OF FLUID. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT PUMP. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. 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 51 YR