BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEPACELL R500II RED CELL LEUKOCYTE REDUCTION FILTER

    MDR report key: 222265 · Received May 4, 1999

    Report

    Report Number
    9612051-1999-00004
    Event Type
    Death
    Date Received
    May 4, 1999
    Date of Event
    March 24, 1999
    Report Date
    May 3, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    CAK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 4/5/99, BAXTER WAS NOTIFIED BY RISK MGMT, AT THE TRANSFUSION SITE, OF A FIBRILE TRANSFUSION REACTION THAT OCCURRED ON 3/24/99. THE PT EXPIRED ON 3/27/99. THE CUSTOMER REPORTED THAT A BAXTER LEUKOREDUCTION FILTER WAS A CONCOMITANT PRODUCT USED IN THE TRANSFUSION. THE CUSTOMER COULD NOT CONFIRM IF A BAXTER BLOOD PACK UNIT WAS ALSO USED IN THE TRANSFUSION. NO OTHER EVENT INFO WAS GIVEN BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPACELL R500II RED CELL LEUKOCYTE REDUCTION FILTER SEPACELL R500II RED CELL LEUKOCYTE REDUCTION FILTER CAK BAXTER HEALTHCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death