BEUDAMED
    FDA Adverse Event Death Summary report: N

    GEMSTAR 7 THERAPY IN

    MDR report key: 3198791 · Received June 25, 2013

    Report

    Report Number
    9615050-2013-01739
    Event Type
    Death
    Date Received
    June 25, 2013
    Date of Event
    October 1, 2011
    Report Date
    April 10, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K083019
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING TESTING, THE DEVICE DELIVERED A MEASURED VOLUME OF 20.02ML EXPECTED DELIVERY OF 20ML. DELIVERY ACCURACY FOR THIS DEVICE REQUIRES DELIVERY OF 20ML +/- 1ML (+/- 5%). THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE DEVICE HISTORY INDICATED AN ERROR CODE 18/000/000 (HISTORY POINTER ERROR WHILE INSERTING A NEW RECORD INTO THE HISTORY LOG) AND ERROR CODE 06/001/017 (INFUSION DATA CRC ERROR) OCCURRED, INDICATING THE "PWAS" (PRINTED CIRCUIT BOARDS) HAD BEEN SEPARATED. THE DEVICE HISTORY ENTRIES PRIOR TO THE ERROR CODES WERE FOUND TO HAVE BEEN LOST DUE TO THE SEPARATION OF THE "PWAS." 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 A PATIENT DEATH WHILE DEVICE IN USE. ON AN UNSPECIFIED DATE AND TIME THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME IT WAS REPORTED THAT THE PATIENT EXPIRED. NO SPECIFIC EVENT DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THE DEVICE WAS UNRELATED TO THE PATIENT'S DEATH. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286817 GEMSTAR 7 THERAPY IN 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death