BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESHIELD NV PRIMARY PIGGYBACK SET

    MDR report key: 1192090 · Received October 7, 2008

    Report

    Report Number
    9613251-2008-00356
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K971293
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT AFTER ARRIVING IN THE RECOVERY ROOM, THE PT HAD DIFFICULTY BREATHING. AT UNSPECIFIED TIMES WHILE IN THE RECOVERY ROOM, THE PT RECEIVED 3 DOSES OF THE DILAUDID 0.5MG IV PUSH. AT 1755, THE PT WAS TRANSFERRED TO THE DAY SURGERY UNIT AND COMPLAINED OF "CHOKING." REPORTEDLY, THE PT BECAME CYANOTIC AND HAD "NO READABLE" OXYGEN SATURATION WITH RESPIRATORY DEPRESSION AND A RESPIRATION RATE OF 4 BREATHES PER MINUTES. THE PT WAS TREATED WITH NARCAN 0.4MG IV PUSH. IT WAS REPORTED THAT THE OXYGEN SATURATION INCREASED TO 99% WITH A RESPIRATORY RATE OF 10 BREATHES PER MINUTE. THE PT WAS TRANSFERRED TO THE ICU FOR OBSERVATION. THE TUBING SET REMAINED IN CLINICAL USE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD NV PRIMARY PIGGYBACK SET 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R DILAUDID