BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLM A+ MEDNET FWV

    MDR report key: 1570981 · Received January 5, 2010

    Report

    Report Number
    2921482-2010-00002
    Event Type
    Death
    Date Received
    January 5, 2010
    Date of Event
    December 5, 2009
    Report Date
    December 7, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. THE DEVICE PASSED TESTING AT THE USER FACILITY. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. THE DEVICE HISTORY INDICATES THAT IN 2009 AT 1631, LINE A OF THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE, WITH A DRUG CONCENTRATION OF 1MG, DILUENT 80ML, WITH A DOSE OF 1MG/HR, FOR A DURATION OF 1 HOUR, AND A RATE OF 80ML/HR AND THE DELIVERY WAS STARTED. AT 1731, THE DEVICE ALARMED THAT THE VOLUME TO BE INFUSED ON LINE A WAS COMPLETE. AT 1732, THE ALARM WAS SILENCED. AT 1736, THE DEVICE WAS TURNED OFF. A REVIEW OF THE DEVICE HISTORY INDICATES THAT THE DEVICE DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. THE DEVICE WAS PROGRAMMED TO DELIVER MORPHINE 1MG/ML, AT A RATE OF 1ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROXIMATELY AN HOUR, THE DEVICE ALARMED FOR AN UNSPECIFIED REASON. AT THIS TIME, IT WAS REPORTED THE NURSE NOTED THE MORPHINE CONTAINER WAS EMPTY AND THE PATIENT HAD EXPIRED. THE PHYSICIAN WAS NOTIFIED AND ORDERED AN UNSPECIFIED CONCENTRATION OF NALOXONE; HOWEVER, THE PATIENT'S FAMILY DECLINED MEDICAL INTERVENTION. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. DURING A REVIEW OF THE DEVICE HISTORY AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED TO DELIVER A CONCENTRATION OF 1MG/80ML INSTEAD OF THE INTENDED CONCENTRATION OF 1MG/ML. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING THE PATIENT'S GENDER AND ADMITTING DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLM A+ MEDNET FWV 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death MORPHINE, MANUFACTURER UNK