BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2121959 · Received June 1, 2011

    Report

    Report Number
    1722028-2011-00150
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK040086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT A "MAJOR" AC REACTION. AT 13 MINUTES, THEY GAVE THE DONOR 4 TUMS AND LOWERED THE DRAW FLOW. A 80 MINUTES, THE DONOR WAS FEELING DIZZY AND "WEIRD" SO THEY ENDED THE PROCEDURE WITHOUT DOING RINSEBACK. THE DONOR WAS EXPERIENCING TIGHTNESS IN THE CHEST, RAPID BREATHING, SKIN WAS PALE AND GREENISH IN COLOR. HE HAD TINGLING AND HAD NUMBNESS AROUND THE LIPS, MOUTH, IN THE ARMS AND HANDS, TETANY IN BOTH ARMS AND LEGS, AND WAS NAUSEATED. THE DONOR REFUSED THE RECOMMENDATION OF GOING TO THE HOSPITAL AT THE TIME OF THE EVENT. THE DONOR FOLLOWED UP WITH HIS PHYSICIAN AND WAS CLEARED TO CONTINUE DONATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 81000

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other