BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMSTAR 7 THERAPY FR

    MDR report key: 2021356 · Received February 8, 2011

    Report

    Report Number
    2921482-2011-00026
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 19, 2010
    Report Date
    January 19, 2011
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 FOR INTERMITTENT DELIVERY OF AN UNSPECIFIED CONCENTRATION OF FORTAZ, WITH A 53ML DOSE AMOUNT, WITH A 12 HOUR DOSE FREQUENCY, FOR 2 DOSES, AN UNSPECIFIED KVO (KEEP VEIN OPEN) RATE, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2011 AT AN UNSPECIFIED TIME, THE NURSE REPORTED THE DEVICE DISPLAY INDICATED THAT 114.6ML HAD BEEN DELIVERED; HOWEVER, THE CONTAINER WAS FULL. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT STATED THERE WAS NO CHANGE IN THE PT STATUS. IT WAS REPORTED THAT THIS WAS THE LAST DAY OF THE TREATMENT FOR THIS PT. THE PHYSICIAN WAS NOTIFIED. NO MEDICAL INTERVENTIONS WERE REQUIRED AND THE PT WAS DISCHARGED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMSTAR 7 THERAPY FR 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK