BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRAVIA EMPTY CONTAINER (250ML) GAMMA STERILIZED

    MDR report key: 975874 · Received December 21, 2007

    Report

    Report Number
    6000001-2007-11187
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    November 16, 2007
    Report Date
    November 30, 2007
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS SENT SAMPLES OF FENTANYL BAGS TO A THIRD PARTY AND THE RESULTS ARE PENDING. SHOULD THE RESULTS BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CORPORATE PRODUCT SURVEILLANCE BECAME AWARE OF FIVE PT INFECTIONS AT HOSPITAL COINCIDENT WITH THE USE OF BAXTER PRODUCTS. THE PT RECEIVED AN INFUSION OF FENTANYL COMPOUNDED BY PHARMEDIUM SERVICES USING THE FOLLOWING BAXTER PRODUCTS: 250ML INTRAVIA BAG. THE 0.9% SODIUM CHLORIDE, AND FENTANYL (FINAL CONCENTRATION OF 10CMG/ML). CURRENTLY THE ACTUAL SAMPLE IS NOT AVAILABLE FOR BAXTER. FOR THIS INCIDENT: THE PT WAS A FEMALE ADMITTED IN 2007 WITH SEPTIC SHOCK AND GROUP A STREPTOCOCCUS. THE PT WAS VENTILATOR DEPENDENT. THE PT CULTURED POSITIVE FOR SPHINGOMONAS PAUCIMOBILIS. THE PT DID NOT RECEIVE ANY CONTRAST DYE OR BLOOD PRODUCTS PRIOR TO TREATMENT. THE PT'S REPORTED CAUSES OF DEATH ARE ACUTE RESPIRATORY DISTRESS SYNDROME AND MULTI ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAVIA EMPTY CONTAINER (250ML) GAMMA STERILIZED 80KPE KPE BAXTER HEALTHCARE CORP. UR391243

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death