BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 4110515 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05245
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 28, 2014
    Manufacturer
    HOSPIRA HOLDINGS DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    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 PROGRAMMED ON (B)(6) 2014 AT 1751, IN THE CONTINUOUS ONLY DELIVERY IN ML MODE, WITH A 12.5ML/HR RATE, A 577ML VTBI (VOLUME TO BE INFUSED), NO KVO RATE WAS SELECTED, AND A CONTAINER SIZE OF 577ML, AIR SENSITIVITY WAS OFF, THE KEYPAD WAS LOCKED AND THE DEVICE WAS POWERED OFF. AT 2236, THE DEVICE WAS POWERED ON AND THE DELIVERY WAS STARTED. A NEW DATE OF (B)(6) 2014 WAS INDICATED. BETWEEN 0820 & 0846, A DISTAL OCCLUSION ALARM OCCURRED, SILENCED X2 AND THE DELIVER WAS STOPPED AND STARTED. BETWEEN 1715 & 1729, A DISTAL OCCLUSION ALARM OCCURRED, A CHECK CASSETTE ALARM OCCURRED, A CASSETTE INSERTED IS INDICATED AND A DISTAL OCCLUSION ALARM OCCURRED. A NEW DATE OF (B)(6) 2014 IS INDICATED. BETWEEN 2018 &2120, THE DEVICE WAS POWERED ON 2X, A 15/000/001 (POWER DOWN ERROR) OCCURRED, POWERED ON USING BATTERIES, THE DELIVERY WAS STOPPED AND STARTED, A CHECK CASSETTE P ALARM OCCURRED AND A POWER LOSS ALARM OCCURRED. 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 THAT THE DEVICE DELIVERED LESS THAN INTENDED. ON (B)(6) 2014 AT 2230, THE DEVICE WAS PROGRAMMED TO DELIVER FLUOROURACIL 3890MG IN 500ML OF 5% DEXTROSE IN WATER, A TOTAL VOLUME OF 566ML, AT A RATE OF 12.6ML/HR WITH A VTBI (VOLUME TO BE INFUSED) OF 566.76ML, FOR A DURATION OF 46 HOURS, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER 46 HRS ON (B)(6) 2014 AT 2022, THE NURSE REPORTED WHEN THE DELIVERY WAS EXPECTED TO BE COMPLETE 151ML OF MEDICATION WAS NOTED TO BE REMAINING IN THE CONTAINER INSTEAD OF THE EXPECTED EMPTY CONTAINER. AT THAT TIME, THE PHYSICIAN WAS NOTIFIED AND THERAPY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, INACCURATE DELIVERY WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573894 GEMSTAR 7 THERAPY 80FRN FRN HOSPIRA HOLDINGS DE COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1