BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM

    MDR report key: 2132464 · Received June 13, 2011

    Report

    Report Number
    1722028-2011-00176
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK010046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE CARIDIANBCT SUPPORT SPECIALIST VERIFIED THROUGH THE EQUIPMENT RUN DATA FILES THAT THE INFO ENTERED FOR THE PROCEDURE WAS FOR A MALE, INSTEAD OF THE FEMALE DONOR'S INFO. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MFG THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: OPERATOR ERROR. CORRECTIVE ACTION: THE SUPPORT SPECIALIST WHO HANDLED THE CALL GAVE THE CUSTOMER SOME RE-TRAINING AS TO THE DANGER OF RUNNING A DONOR WITH THE WRONG PARAMETERS.

    Description of Event or Problem · 1

    THE OPERATOR CALLED BECAUSE THEY THOUGHT THEY HAD SELECTED A PLASMA ONLY PROCEDURE BUT THE DEVICE BEGAN COLLECTING RBCS AT 8 MINS INTO THE PROCEDURE. UPON FURTHER INVESTIGATION BY THE CARIDIANBCT SUPPORT SPECIALIST, IT WAS FOUND THAT INITIALLY THE INFO FOR A MALE DONOR, (B)(6), WAS PUT INTO THE TRIMA AND A DOUBLE RED CELL COLLECTION PROCEDURE WAS SELECTED (THIS MALE DONOR HAD BEEN MOVED TO A DIFFERENT MACHINE). A FEMALE DONOR WAS THEN PUT INTO THE MACHINE THAT HAD THE MALE DONOR'S INFO STILL ENTERED INTO IT. THE PROCEDURE WAS BEGUN WITHOUT CHANGING THE DONOR INFO. THE DONOR WAS FINE AND NO MEDICAL INTERVENTION WAS NECESSARY. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY DUE TO OVER-ANTICOAGULATION.

    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 54 YR Other