BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEPACELL PLS10A LEUKOCYTE REDUCTION Y-ADMIN SET

    MDR report key: 538452 · Received August 11, 2004

    Report

    Report Number
    1420141-2004-00035
    Event Type
    Other
    Date Received
    August 11, 2004
    Date of Event
    July 16, 2004
    Report Date
    July 16, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED TO BAXTER CLINICAL EDUCATION A TRANSFUSION REACTION THAT OCCURRED AFTER TRANSFUSION OF 5 TO 10 ML OF A SINGLE DONOR APHERESIS PLATELET FILTERED WITH 4C4502 PRODUCT CODE. THE PT EXPERIENCED NAUSEA, CYANOSIS AND A DECREASE IN BLOOD PRESSURE TO 60/40 WHEN THE TRANSFUSION WAS DISCONTINUED. THE PT WAS TRANSFERRED TO ICU FOR OBSERVATION. THE PT DID NOT EXPERIENCE A RISE IN TEMPERATURE OF A DEGREE OR MORE DUE TO THE TRANSFUSION REACTION. FOLLOW-UP WITH THE PHYSICIAN AT THE ACCOUNT 5 DAYS LATER INDICATED THAT THE PT HAD FULLY RECOVERED FROM THE TRANSFUSION REACTION AND DID NOT REQUIRE MEDICAL INTERVENTION OTHER THAN DISCONTINUING THE TRANSFUSION AND MONITORING IN ICU. THE PT WAS NOT TREATED FOR POSSIBLE BACTERIAL CONTAMINATION FROM THE PLATELET TRANSFUSION DUE TO THE INITIAL POSITIVE TEST RESULT ON THE PLATELET APHERESIS NOT BEING CONFIRMED PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPACELL PLS10A LEUKOCYTE REDUCTION Y-ADMIN SET SEPACELL SETS CAK BAXTER HEALTHCARE CORP 4C4502 A04C17061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization SINGLE-DONOR APHERESIS PLATELETS 2004.