BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY

    MDR report key: 1873687 · Received September 21, 2010

    Report

    Report Number
    2921482-2010-00728
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 INACCURATE DELIVERY. ON (B)(6) 2010 AT 1300, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF 5FU, AT RATE OF 0.4ML/HR, WITH A 76.8ML VTBI (VOLUME TO BE INFUSED), AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE THERAPY WAS TO DELIVER FOR A DURATION OF 8 DAYS. ON (B)(6) 2010 AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PT WENT TO THE PHYSICIAN'S OFFICE DUE TO A "9-05-100" ALARM CONDITION. AT THAT TIME, THE BATTERIES WERE CHANGED AND THE DELIVERY WAS RESTARTED. ON (B)(6) 2010 AT 0200, THE PT REPORTED THE DEVICE ALARMED "INFUSION COMPLETE" WHICH WAS EARLIER THAN EXPECTED. AT 0930, THE PT WENT TO THE PHYSICIAN OFFICE. AT THAT TIME, THE NURSE REPORTED THE DEVICE DISPLAY INDICATED THAT 62.5ML HAD BEEN DELIVERED; HOWEVER, IT WAS REPORTED THAT 57ML REMAINED IN THE CONTAINER. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PHYSICIAN WAS NOTIFIED. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE CUSTOMER CONTACT REPORTED THERE WAS NO CHANGE IN THE PT STATUS OR DELAY IN THERAPY CRITICAL TO THE PT. NO MEDICAL INTERVENTIONS WERE REPORTED. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THOUGH REQUESTED, NO ADDITIONAL INFO 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 69 YR GEMSTAR LIST # 13273, LOT# UNK