BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 2110921 · Received May 3, 2011

    Report

    Report Number
    2921482-2011-00058
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 4, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 20.08ML 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 MFG FACILITY. A REVIEW OF THE PUMP HISTORY INDICATED ON (B)(4) 2010, THE DELIVERY WAS PROGRAMMED TO DELIVER IN THE CONTINUOUS ONLY DELIVERY IN ML, AT A RATE OF 4.4ML/HR, A 200ML VTBI, AND A 210ML CONTAINER SIZE. THE DEVICE CONTINUED IN USE AND ON (B)(4) 2011 AT 1841, NEW CONTAINER WAS STARTED. AT 0000, A NEW DATE STAMP OF (B)(4) 2011 OCCURRED. BETWEEN 2046 & 2154, A CHECK CASSETTE ALARM (A) AND CASSETTE INSERTED OCCURRED 3 TIMES. A NEW DATE STAMP OF (B)(4) 2011 OCCURRED. BETWEEN 0509 & 1021, A CHECK CASSETTE ALARM (A) AND CASSETTE INSERTED OCCURRED 59 TIMES. BETWEEN 1029 & 1039, THE DELIVERY WAS STOPPED, A START ALARM OCCURRED 2 TIMES, SILENCED 2 TIMES, DELIVERY STARTED, STOPPED AND A POWER LOSS ALARM OCCURRED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "PT WAS HOOKED UP TO A FLUOROURACIL (5FU) HOME INFUSION PUMP. IT WAS TO RUN FOR 46 HOURS, BUT FINISHED 7 HOURS EARLY. THE PUMP STARTED BEEPING & IT WAS NOTED THAT THE IV BAG WAS EMPTY SO THE PUMP WAS STOPPED & DISCONNECTED BY PT'S WIFE." UPON FURTHER QUERY, THE FOLLOWING WAS PROVIDED THAT INDICATED, THE PT RECEIVED MORE MEDICATION THAN INTENDED. ON (B)(6) 2011 AT 1841, THE DEVICE WAS PROGRAMMED TO DELIVER 5FU 4368MG/200ML, AT A RATE OF 4.4ML/HR, FOR A 46 HOUR DURATION, WITH A 200ML VTBI (VOLUME TO BE INFUSED), CONTAINER SIZE OF 210ML AND DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2011 AT 1029, THE PT REPORTED THE DEVICE "BEEPED" AND THE CONTAINER WAS EMPTY INSTEAD OF AN EXPECTED 34ML TO BE REMAINING. THE DEVICE WAS REMOVED FROM CLINICAL SVC. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTR 7 THPY ALT ST 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR