BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 3150538 · Received May 30, 2013

    Report

    Report Number
    9615050-2013-01448
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 5, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011442
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE DEVICE HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES ON (B)(6) 2013 AT 0813, LINE A OF THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE, CCU CCA, TO DELIVER NOREPINEPHRINE 12MG/250ML WITH A DOSE OF 0.300MCG/KG/MIN, WEIGHT (B)(6), AT A RATE OT 21.4ML/HR, VTBI (VOLUME TO BE INFUSED) OF 250ML, FOR A DURATION OF 11 HOURS, 40 MINUTES, AND THE DELIVERY WAS STARTED. BETWEEN 0814 AND 0935, THE RATE WAS TITRATED UP AND DOWN FROM 0.0-0.5MCG/KG/MIN SIX TIMES. A REVIEW OF THE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED. 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 THE PT RECEIVED MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF NOREPINEPHRINE AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THE DELIVERING RATE OF THE NOREPINEPHRINE WAS TITRATED ACCORDING TO THE PT VITAL SIGNS. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE PT EXPIRED. IT WAS REPORTED THE CAUSE OF DEATH WAS DUE TO THE PT'S HEALTH STATUS. THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT CONTRIBUTE TO THE PT'S DEATH. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED, INCLUDING SPECIFIC EVENT DETAILS AND IF ANY MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238102 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death NOREPINEPHRINE, MFR UNK| PLUM A+ SOFTWARE MODULE, LIST #12097, SN (B)(4)