BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIMA ACCEL PLT, PLS, RBC FRENCH SET

    MDR report key: 2087890 · Received May 2, 2011

    Report

    Report Number
    1722028-2011-00076
    Event Type
    Other
    Date Received
    May 2, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 28, 2011
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    BK030083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THIS SET WAS NOT RECEIVED FOR INVESTIGATION BECAUSE IT WAS DISCARDED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM A PHYSICIAN AT THIS SITE: THE LRS TUBING WAS CUT AT THE NARROW END OF THE LRS CHAMBER (AT FEW MM FROM THE NARROW END). THE CUT WAS NEAT, AND WAS LINKED TO A PULLED TUBING. AT THE TIME IT OCCURRED, NO BLOOD WAS IN THE LRS CHAMBER. THERE WAS BLOOD IN THE CHANNEL. ROOT CAUSE: BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM A PHYSICIAN AT THIS SITE AND THE EARLY STAGE OF THE COLLECTION AT WHICH THE FAILURE OCCURRED, THE DEFECT WAS LIKELY RELATED TO THE LRS CHAMBER NOT BEING LOADED CORRECTLY INTO THE LRS BRACKET IN THE CENTRIFUGE DURING THE RUN, AS A PORTION OF TUBING WAS STILL ATTACHED TO THE NARROW END OF THE LRS CHAMBER (CUT AT THE NARROW END OF THE LRS CHAMBER, AT FEW MM FROM THE NARROW END). THIS DEFECT IS NOT LIKELY RELATED TO AN INADEQUATE BOND AT THIS LOCATION. CONCLUSION: THE LRS CHAMBER SEPARATED FROM THE TUBING SET, PROBABLY FROM A MISLOAD.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE CONTINUE TO REFINE OUR MDR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. WE REGRET THAT THIS CHANGE HAS CAUSED THIS MDR TO BE FILED OUTSIDE THE REQUIRED TIMEFRAME. THE LRS (LEUKOCYTE REDUCTION SYSTEM,) CHAMBER WAS DISCONNECTED FROM THE TUBING SET. NO BLOOD WAS IN THE LRS CHAMBER, BUT THERE WAS BLOOD IN THE CHANNEL. CYTAPHERESIS STOPPED 30 SECONDS AFTER STARTING AND PATIENT DISCONNECTED. NO SAFETY ISSUE OCCURRED, NOR WAS ALLEGED TO BE LIKELY TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL PLT, PLS, RBC FRENCH SET SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT 11R3209

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other