BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-TYPE BLOOD SOLUTION SET

    MDR report key: 297829 · Received September 26, 2000

    Report

    Report Number
    6000001-2000-00542
    Event Type
    Death
    Date Received
    September 26, 2000
    Date of Event
    August 11, 2000
    Report Date
    August 29, 2000
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCT. REPORTS THAT DURING A BLOOD TRANSFUSION OF PACKED RED CELLS A PT DEVELOPED A FEBRILE REACTION AND DIED THE NEXT DAY. THE PT HAD BLOOD CULTURES PERFORMED APPROX ONE HOUR AFTER THE REACTION AND PT'S BLOOD REVEALED AN ENTEROBACTER SPECIES. THE SAME ORGANISM WAS CULTURED OUT OF THE INJECTION PORT ON THE SET. THE CULTURES PERFORMED ON THE BLOOD BAGS WERE NEGATIVE WITH NO GROWTH. 08/30/2000 ADD'L INFO REC'D. THE ACTUAL LOT NUMBER INVOLVED IS UNKNOWN. THE TWO LOT NUMBERS PRESENT ON THE CUSTOMER'S SHELF ARE GR135103 AND GR138149. CONTACT ALSO STATED THE INJECTION SITE THAT TESTED POSITIVE FOR THE CULTURE WAS THE SITE CLOSEST TO THE PT. PT HAD DIAGNOSIS OF "CLL" AND WAS A DO NOT RESUSCITATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Y-TYPE BLOOD SOLUTION SET BLOOD SET KSB BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN