BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLATELET SET

    MDR report key: 1963357 · Received January 10, 2011

    Report

    Report Number
    1722028-2011-00003
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    January 6, 2010
    Report Date
    January 10, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    GKT
    PMA / PMN Number
    BK0083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT WAS REPORTED TO THE COMPANY WHILE THE COMPANY WAS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION ON OTHER EVENTS. THE CUSTOMER REPORTED THAT THEY COULD NOT PROVIDE ANY ADDITIONAL INFORMATION SINCE THOSE INVOLVED ARE NO LONGER AT THE DONOR CENTER.

    Description of Event or Problem · 1

    DONOR PALE, LIGHTHEADED, HOT AND DIAPHORETIC, WITH LOC FOR 10 SEC. DONOR PLACED IN SUPINE POSITION, HOB LOWERED, FLUID GIVEN AND KNEES WERE ELEVATED, COLD PACK APPLIED, AND INSTRUCTIONS GIVEN. DONOR RECOVERED IN 20 MIN. FOLLOW UP CALL ON (B)(6) 2010, MESSAGE LEFT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLATELET SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL GKT CARIDIANBCT 11R1106

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other