BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS GERMAN SET

    MDR report key: 2253165 · Received September 1, 2011

    Report

    Report Number
    1722028-2011-00105
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    August 10, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK100032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE TRIMA ACCEL SET WAS RETURNED FOR INVESTIGATION. THE SET WAS VISUALLY INSPECTED AND DRIED BLOOD AND A LEAK PATH WERE OBSERVED IN THE SINGLE SIDE OF THE CONTROL-Y BOND. THE Y WITH TUBING WAS CUT FROM THE SET TO VERIFY THE LEAK PATH. THE BOND WAS TESTED WITH PRESSURIZED AIR AND THE LEAK PATH WAS VERIFIED AT THE SINGLE SIDE OF THE CONTROL-Y. THE TUBING AT THE SINGLE SIDE OF THE CONTROL-Y WAS NOTED TO HAVE A 4 MM BOND GAP (I.E. - THE TUBING HAD BEEN INADEQUATELY INSERTED). TRENDS SUGGEST THAT THE EVENT REPORTED IS RANDOM AND OCCURS AT A LOW LEVEL ON A GENERAL BASIS. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED BY THE COMPLAINT INVESTIGATOR IN RELATION TO THIS FAILURE MODE. FOR THIS DISPOSABLE LOT NUMBER, THERE WERE NO IN-PROCESS NON-CONFORMITIES, NO ENGINEERING CHANGE ORDER,S AND A SINGLE UNRELATED IN-PROCESS INSPECTION OBSERVATION. THERE WERE NO SIMULATED TESTING OBSERVATIONS OR FAILURES. THE PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: THE CAUSE OF THIS DEFECT IS INADEQUATE INSERTION OF THE TUBING INTO THE BOND SOCKET OF THE Y CONNECTOR DURING MANUFACTURING.

    Description of Event or Problem · 1

    DURING A BLOOD COMPONENT COLLECTION PROCEDURE (APPROXIMATELY FIVE MINUTES FROM THE START) A LEAK OCCURRED IN THE CENTRIFUGE. NO MEDICAL INTERVENTION OCCURRED. THIS COMPLAINT WAS SUBMITTED TO CARIDIANBCT ON (B)(4) 2011, AND WAS ENTERED INTO OUR COMPLAINT SYSTEM ON (B)(6) 2011. AT THIS TIME, NO ALLEGATION OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION WAS MADE BY THE CUSTOMER. FOLLOWING THE STANDARD COMPLAINT INVESTIGATION PROCEDURE, THIS RECORD WAS EVALUATED, COMPLETED, AND CLOSED ON (B)(4) 2011. AS OF (B)(4) 2011, CARIDIANBCT BECAME AWARE THAT THE CUSTOMER HAD MADE A REGULATORY SUBMISSION OF THIS COMPLAINT, VIA A USER REPORT, TO THEIR REGIONAL AUTHORITIES ((B)(4)). THUS THIS MDR IS BEING FILED AS A PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS GERMAN SET AUTOMATED BLOOD CELL SEPARATOR LKN CARIDIANBCT 11S2130

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR