BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL ENH PLT, PLS, RBC, AUTO RBC SET

    MDR report key: 2210052 · Received July 27, 2011

    Report

    Report Number
    1722028-2011-00255
    Event Type
    Other
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 1, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE RUN DATA FILE (RDF) WAS ANALYZED. THE SIGNALS IN THE RDF INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED. THE SIGNALS DO NOT INDICATE A CLEAR CAUSE FOR THE HIGHER THAN EXPECTED PLASMA PRODUCT VOLUME. IT CANNOT BE CONFIRMED THROUGH RDF ANALYSIS, BUT IT IS POSSIBLE THAT THE PLASMA LINE COULD HAVE BEEN SEALED OR CLAMPED DURING RINSEBACK, BEFORE PLASMA RINSEBACK HAD STARTED. THIS COULD RESULT IN A HIGHER THAN EXPECTED PLASMA PRODUCT VOLUME. INVESTIGATION EVAL AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED THAT THE RUN DATA FILE BE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE HIGHER THAN EXPECTED PLASMA PRODUCT VOLUME. NO MEDICAL INTERVENTION WAS NECESSARY. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED AT THE CUSTOMER SITE. THIS REPORT IS BEING FILED DUE TO THE POTENTIAL FOR INJURY FROM HYPOVOLEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL ENH PLT, PLS, RBC, AUTO RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 04T3208

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR