BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2211360 · Received August 4, 2011

    Report

    Report Number
    1722028-2011-00276
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK010046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CARIDIANBCT SUPPORT SPECIALIST REMINDED THE CUSTOMER ABOUT THE IMPORTANCE OF ENTERING THE CORRECT DONOR INFO AND HOW INACCURATE DOOR INFO COULD AFFECT THE PROCEDURE AND DONOR. THE CARIDIANBCT SUPPORT SPECIALIST ALSO CONTACTED THE SALES REP FOR THIS CUSTOMER FOR A POTENTIAL RE-TRAINING OPPORTUNITY. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A F/U REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED END OF RUN SUMMARY DATE DUE TO ONE OF THEIR OPERATORS POSSIBLY ENTERING THE WRONG DONOR INFO DURING A SINGLE PRODUCT PLATELET PROCEDURE. THE OPERATOR INCORRECTLY ENTERED A HEIGHT OF (B)(6) FEET INSTEAD OF (B)(6), WHICH IS DONOR'S ACTUAL HEIGHT. THIS RESULTED IN A FALSELY HIGH TBV. THE DONOR WHO WAS INVOLVED IN THIS INCIDENT REPORTEDLY HAD NO REACTION AT ALL. NO MEDIAL INTERVENTION WAS NECESSARY. THIS REPORT IS BEING FILED DUE TO POTENTIAL FOR INJURY FROM OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 917000000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other