BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTR 7 THPY ALT ST

    MDR report key: 1915431 · Received November 4, 2010

    Report

    Report Number
    2921482-2010-00862
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 20.10ML 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 MFR FACILITY. A REVIEW OF THE HISTORY INDICATES ON (B)(6) 2010 AT 1334, THE DEVICE WAS PROGRAMMED FOR CONTINUOUS ONLY DELIVERY IN ML, WITH A RATE OF 2ML, VTBI 96ML, 0ML KVO RATE, A CONTAINER SIZE OF 96ML, AIR SENSITIVITY OFF. BETWEEN 1335 AND 1342, A PRIMING VOLUME OF 4.9ML IS INDICATED, A START ALARM OCCURRED, SILENCED AND THE DELIVERY WAS STARTED. A NEW DATE STAMP IS INDICATED AT 0000 ON (B)(6) 2010 AND (B)(6) 2010. AT 1118, AN EMPTY CONTAINER ALARM OCCURRED. AT 1119, A POWER LOSS ALARM OCCURRED. AT 1143, THE DEVICE WAS POWERED ON USING BATTERIES. AT 1159, AN EMPTY CONTAINER ALARM OCCURRED AND SILENCED. AT 1205, 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 DEVICE DID NOT DELIVER. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF 5FU (FLUOROURACIL), AT A RATE OF 2ML/HR, WITH A VTBI (VOLUME TO BE INFUSED), OF 92ML, FOR A DURATION OF 46HRS AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED AFTER 46 HOURS, THE DISPLAY INDICATED THE EXPECTED VOLUME HAD BEEN DELIVERED; HOWEVER, THE CONTAINER WAS "STILL FULL." THE PHYSICIAN WAS NOTIFIED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED WITH A REPLACEMENT DEVICE WITH THE NEXT SCHEDULED DOSE. THE CUSTOMER CONTACT REPORTED THERE WAS NO CHANGE IN PT STATUS. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THOUGH REQUESTED, NO ADD'L 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 GEMSTAR TUBING SET LIST # 13273, LOT # UNK