BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIAFLEX EMPTY CONTAINER (3000) W/CONNECTOR

    MDR report key: 975873 · Received December 21, 2007

    Report

    Report Number
    6000001-2007-11186
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    November 16, 2007
    Report Date
    December 4, 2007
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER PERFORMED A BATCH REVIEW FOR THE PRODUCT CODE AND LOT NUMBER. NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING OF THIS LOT.

    Description of Event or Problem · 1

    CORPORATE PRODUCT SURVEILLANCE BECAME AWARE OF A CLUSTER (5) OF SPHINGOMONAS PAUCIMOBILIS INFECTIONS IN 2007 AT JOHNS HOPKINS 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, 0.9% SODIUM CHLORIDE, AND FENTANYL (FINAL CONCENTRATION OF 10MCG/ML) AND VIAFLEX POOLING BAG. FOR THIS INCIDENT: THE PT WAS A FEMALE ADMITTED ON THE FOLLOWING MONTH, WITH SEPTIC SHOCK AND GROUP A STREPTOCOCCUS. THE PT WAS VENTILATOR DEPENDENT. POSITIVE CULTURES WERE OBTAINED FROM THE FENTANYL BAG BY THE FACILITY. THE PT DID NOT RECEIVED 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 VIAFLEX EMPTY CONTAINER (3000) W/CONNECTOR 80KPE KPE BAXTER HEALTHCARE CORP. UE114348

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death