BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LS CNVT PLMSET-OL

    MDR report key: 1062086 · Received June 17, 2008

    Report

    Report Number
    9615050-2008-00169
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 21, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD
    Product Code
    FPA
    PMA / PMN Number
    K933326
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR WHICH RESULTED IN AN ADVERSE PT EVENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN. AT 1800, IT WAS REPORTED A NURSE CHANGED THE TUBING SET AND SOLUTION CONTAINER. AT 2000, A DIFFERENT NURSE NOTED THAT THE CASSETTE WAS NOT LOADED INTO THE PUMP; HOWEVER, THE TPN WAS INFUSING. THE PT'S BLOOD GLUCOSE WAS CHECKED AND WAS REPORTED TO BE 255MG/DL. THE TPN DELIVERY WAS DISCONTINUED FOR APPROXIMATELY 1 HOUR. THE PT'S BLOOD GLUCOSE WAS RECHECKED AND WAS "FOUND TO BE LOW." THE PT WAS THEN TREATED WITH AN UNSPECIFIED VOLUME OF AN UNSPECIFIED IV FLUID. APPROXIMAL 1 1/2 TO 2 HOURS LATER, IT WAS REPORTED THE PT'S BLOOD GLUCOSE HAD RETURNED TO "NORMAL". THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS CNVT PLMSET-OL 80-FPA FPA HOSPIRA DE COSTA RICA LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R TPN