BEUDAMED
    FDA Adverse Event Summary report: N

    NONE

    MDR report key: 1284984 · Received January 12, 2009

    Report

    Report Number
    2013342-2009-00001
    Date Received
    January 12, 2009
    Date of Event
    November 14, 2008
    Report Date
    January 7, 2009
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDSEP SET UTILIZED IN COLLECTION OF THE BLOOD PRODUCTS USED IN THE TRANSFUSION WAS PRODUCT CODE 726-92Q, "LEUKOTRAP WB, VENTED, DOUBLE BAG CP2D/AS3 ANTICOAGULANT, 450ML, WITH SAMPLE DIVERSION POUCH", LOT NUMBER 0800708. A REVIEW OF THE LOT IN QUESTION SHOWED THE LOT MET ALL RELEASE SPECIFICATIONS, AND THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED FOR THIS LOT. STERILIZATION RECORDS FOR THIS LOT WERE REVIEWED AND SHOWED NO DEVIATIONS FROM THE VALIDATED STERILIZATION PROCESS AND CYCLE. ENVIRONMENTAL MONITORING DATA WERE REVIEWED AND FOUND NO SITES OUTSIDE OF THEIR SPECIFIED LIMITS. NO ATYPICAL ENVIRONMENTAL CONDITIONS WERE RECORDED. THE INVESTIGATIONS COULD NOT DETERMINE THE CAUSE OF THE REPORTED CONTAMINATION. THERE IS NO EVIDENCE THIS LOT CAUSED OR CONTRIBUTED TO THIS EVENT. THIS PRODUCT, THE PARTICULAR LOT, IS NOT FOR SALE IN THE UNITED STATES. HOWEVER, SIMILAR PRODUCTS HAVE BEEN SOLD IN THE U.S. YET AGAIN, NOT THIS SPECIFIC PRODUCT LOT. UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

    Description of Event or Problem · 1

    THE MALE PATIENT WITH ANEMIA, CHRONIC HEART FAILURE AND CHRONIC OBSTRUCTIVE LUNG DISEASE. HE WAS TRANSFUSED IN 2008 WITH A UNIT OF BLOOD DRAWN TWO WEEKS PRIOR USING PRODUCT 726-92Q (LOT 0800708). THE TRANSFUSION WAS STOPPED AFTER APPROXIMATELY 1/4 OF THE UNIT WAS INFUSED BECAUSE THE PATIENT EXHIBITED CHILLS, DYSPNEA, HYPOTENSION, AND TACHYCARDIA. THE PATIENT WAS TRANSFERRED TO AGGRESSIVE CARE AND DIED SHORTLY THEREAFTER. THIS EVENT OCCURRED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GKT

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death