BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL ENHANCED PLT, PLS, RBC SET

    MDR report key: 2221933 · Received August 17, 2011

    Report

    Report Number
    1722028-2011-00294
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK110009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RUN DATA FILE WAS ANALYZED. SIGNALS INDICATE THAT THE PLASMA LINE MAY HAVE BEEN PARTIALLY OCCLUDED DURING A PORTION OF THE PROCEDURE. IF THE PLASMA LINE DOES NOT CONTRIBUTE PROPERLY TO THE PLATELET PUMP, IT COULD CAUSE THE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN THE SYSTEM EXPECTS, THEREFORE ALLOWING SOME WBCS TO ESCAPE AND END UP IN THE PRODUCT BAG. AN OCCLUDED PLASMA LINE CAN ALSO CONTRIBUTE TO LOW PLASMA PRODUCT VOLUME. ORIENTATION OF THE HEX IN THE HEX HOLDER MAY CONTRIBUTE TO THIS STIMULATION. A REVIEW OF THE MFG RECORDS WAS CONDUCTED. THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: BASED ON THE RDF ANALYSIS, THE PLASMA LINE WAS OCCLUDED DURING THE PROCEDURE. THE PLASMA LINE MAY BECOME OCCLUDED IF THE CENTRIFUGE COLLAR IS NOT LOADED INTO THE LATCH IN THE CORRECT ORIENTATION. UNDER THESE CONDITIONS, THE RBC LINE IS ALLOWED TO LIE ON TOP OF THE PLASMA LINE AND, UNDER CERTAIN FLOW CONDITIONS, MAY CAUSE THE PLASMA LINE TO PINCH OFF. THIS IN TURN CAUSES HIGHER FLOW THROUGH THE LRS CHAMBER, WHICH MAY LEAD TO ELEVATED LEVELS OF WBCS IN THE PLATELET PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER WOULD LIKE THE RUN DATA FILE INVESTIGATED TO DETERMINE A POSSIBLE CAUSE FOR THE LOWER THAN EXPECTED MEASURED PLASMA PRODUCT VOLUME AND THE ELEVATED WBC COUNT IN THE PLATELET PRODUCT. NO MEDICAL INTERVENTION WAS NECESSARY. DONOR UNIT #: (B)(6). THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE THE KIT WAS DISCARDED ON THE SAME DAY AS THE PROCEDURE. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL ENHANCED PLT, PLS, RBC SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 06T1122

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other