BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2121935 · Received June 1, 2011

    Report

    Report Number
    1722028-2011-00149
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK010050
    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 92 MINUTES, THE DONOR WAS HAVING A LOT OF CHEST PAIN AND STOMACH PAIN. THE DONOR WAS GIVEN 6 TUMS AND 911 WAS CALLED PER THE CUSTOMER SITE'S SOP. THE DONOR WAS TAKEN BY AMBULANCE TO (B)(6). THE DONOR SPENT THE NIGHT IN THE EMERGENCY ROOM AND WAS RELEASED THE NEXT MORNING. THE DONOR FOLLOWED UP WITH HIS PHYSICIAN. HIS PHYSICIAN TOLD HIM HE WAS DEHYDRATED AND THAT HE COULD CONTINUE TO DONATE IF HE INCREASED HIS FLUIDS A COUPLE OF DAYS BEFORE THE DONATION.

    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 917000000

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization