BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMICUS APHERESIS KIT-CLSD DBL NDL

    MDR report key: 367709 · Received December 19, 2001

    Report

    Report Number
    1420141-2001-00029
    Event Type
    Death
    Date Received
    December 19, 2001
    Date of Event
    November 9, 2001
    Report Date
    November 27, 2001
    Manufacturer
    SAN GERMAN
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    11/2001-BAXTER CLINICAL EDUCATION DEPARTMENT WAS NOTIFIED OF AN ALLEGED PT DEATH FOLLOWING TRANSFUSION OF A SPLIT PLATELET PRODUCT. THE PLATELET PRODUCT WAS OBTAINED USING THE AMICUS CELL SEPARATOR. 11/2001-FOLLOW-UP BY PRODUCT SURVEILLANCE INDICATED THAT 13 MINUTES INTO TRANSFUSION OF THE SPLIT PLATELET PRODUCT, THE PT EXHIBITED RIGORS WITH CHILLS AND AN INCREASE IN BODY TEMPERATURE WITH SUBSEQUENT DROP IN BLOOD PRESSURE. TRANSFUSION WAS TERMINATED APPROX 2 MINUTES AFTER SYMPTOMS. THE PT WAS TREATED WITH VARIOUS ANTIBIOTICS (VANCOMYCIN, TOBRAMYCIN, CEFTANADINE, ACYTLOVINE). 11/2001-THE PT EXPIRED. PT INFO: PT WITH NEUTROPENIA/LEUKEMIA. PT WAS ON VANCOMYCIN PRIOR TO TRANSFUSION REACTION. PT'S HISTORY INDICATES THAT ON 9/2001, PT DEVELOPED HIVES DURING RED CELL TRANSFUSION. DONATION INFO: REPEAT APHERESIS DONOR. TEMP:98.3 F; TOTAL WB PROCESSED: 3803ML; TOTAL ACD 392ML; WB/ACD RATIO: 10:1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57703 AMICUS APHERESIS KIT-CLSD DBL NDL AMICUS GKT SAN GERMAN NA N01I25015

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death