BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 2770987 · Received October 3, 2012

    Report

    Report Number
    1722028-2012-00778
    Date Received
    October 3, 2012
    Date of Event
    June 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK110009
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LEAK AT THE TUBE SEAL POINT OCCURRED. THIS WAS A PLATELET COLLECTION. THE LEAK HAPPENED IN THE LABORATORY, WHEN NO DONOR OR PATIENT WAS PRESENT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME THAT THE LEAK OCCURRED, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA SET GKT TERUMO BCT 10T2122

    Patients

    Seq Age Sex Outcome Treatment
    1